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2. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration Chroma and Spectri Phase 3 Randomized Clinical Trials

Author

Holz, Fg, Sadda, Sr, Busbee, B, Chew, Ey, Mitchell, P, Tufail, A, Brittain, C, Ferrara, D, Gray, S, Honigberg, L, Martin, J, Tong, B, Ehrlich, Js, Bressler, Nm, Sola, Ff, Schlottmann, P, Zambrano, A, Zeolite, C, Arnold, J, Gillies, M, Luckie, A, Schneltzer, N, de Zaeytijd, J, Boyd, S, Cruess, A, Kertes, P, Lalonde, L, Maberley, D, Laugesen, C, Bodaghi, B, Cohen, Sy, Francais, C, Souied, E, Tadayoni, R, Altay, L, Eter, N, Feltgen, N, Framme, C, Grisanti, S, Holz, F, Pauleikhoff, D, Seres, A, Vajas, A, Varsanyi, B, Boscia, F, Parravano, Mc, Ricci, F, Viola, F, Rechy, Dl, Morales, V, Dijkman, G, Schlingemann, R, Reategui, G, Raczynska, D, Romanowska-Dixon, B, Teper, S, Kacerik, M, Lipkova, B, Oddelenie, O, Mikova, H, Araiz, J, Arias, L, Mataix, J, Mones, J, Montero, J, Sararols, L, Michels, S, Brand, C, Dhillon, B, Agarwal, A, Alfaro, V, Baker, B, Berger, B, Bhisitkul, R, Blodi, B, Boyer, D, Brooks, Hl, Burgess, S, Busquets, M, Callanan, D, Chan, C, Chang, J, Chen, S, Combs, J, Dhoot, D, Dugel, P, Eichenbaum, D, Feist, R, Ferrone, P, Fine, H, Fortun, J, Fox, Ga, Fu, A, Gentile, R, Ghorayeb, G, Gill, M, Gonzalez, V, Gordon, C, Gupta, S, Hampton, R, Heier, J, Hershberger, V, Higgins, P, Ie, D, Isernhagen, R, Katz, R, Kokame, G, Kwun, R, Lee, P, Lee, S, Mansour, S, Marcus, D, Maturi, R, Michels, M, Moore, J, Nielsen, J, Novalis, G, Ober, M, Olsen, K, Patel, S, Pieramici, D, Raskauskas, P, Rofagha, S, Ruby, A, Schneiderman, T, Schwartz, S, Shah, R, Sheth, V, Singerman, L, Singh, R, Sjaarda, R, Stoller, G, Stoltz, R, Suner, I, Tabassian, A, Tarantola, R, Thach, A, Ufret-Vincenty, R, Wirthlin, R, Witkin, A, Wong, R, Wood, M, Zheutlin, J, Alezzandrini, A, Cartier, Mm, Chauhan, D, Chen, F, Gilhotra, J, Guymer, R, Kwan, A, Schmidt-Erfurth, U, Jacob, J, Postelmans, L, Larsen, M, Garcher, Cc, Bocage, C, Devin, F, Kodjikian, L, Korobelnik, Jf, Said, Sm, Weber, M, Agostini, H, Auffarth, G, Bartz-Schmidt, U, Bell, K, Gamulescu, A, Hattenbach, L, Lohmann, Cp, Wolf, A, Nemeth, J, Vamosi, P, Bandello, F, Eandi, C, Lanzetta, P, Nicolo, M, Staurenghi, G, Virgili, G, Franco, Rg, Estudillo, Jr, Hoyng, C, Fernandez, C, Guzman, M, Lujan, S, Herba, E, Kaluzny, J, Misiuk-Hojlo, M, Nawrocki, J, Carneiro, A, Figueira, J, Silva, R, Vaz-Pereira, S, Abdulaeva, E, Erichev, V, Zolotarev, A, Cernak, A, Figueroa, M, Gallego-Pinazo, R, Garcia-Layana, A, Ulla, Fg, Navarro, R, Ortiz, Jm, Imaz, Rt, Kvanta, A, Hatz, K, Wolf, S, Eldem, B, Kir, N, Mentes, J, Saatci, O, Yilmaz, G, Bailey, C, Banerjee, S, Browning, A, Esposti, S, Gale, R, Ghanchi, F, Jackson, T, Lotery, A, Mahmood, S, Mohamed, Q, Narendran, N, Pearce, I, Williams, M, Abraham, P, Abrams, G, Adrean, S, Antoszyk, A, Baker, C, Breazeale, R, Bridges, Wz, Brown, Dm, Calzada, J, Campochiaro, P, Chaudhry, N, Clark, L, Connolly, B, Csaky, K, Do, D, Dreyer, R, Durant, W, Eaton, A, Feiner, L, Ferreyra, H, Flaxel, C, Foxman, S, Freund, Kb, Gonzales, Cr, Gordon, A, Halperin, L, Ho, A, Holekamp, N, Husain, D, Jain, N, Javid, C, Johnson, M, Kiss, S, Lad, E, Leng, T, Liu, M, London, N, Madow, B, Miller, D, Morse, L, Ohr, M, Oliver, S, Pearlman, J, Ray, Sk, Regillo, C, Rosa, R, Rosenfeld, P, Saperstein, D, Sarraf, D, Shildkrot, Y, Suan, E, Weishaar, P, Wieland, M, Williams, D, Williams, J, Wykoff, Cc, Ophthalmology, ACS - Atherosclerosis & ischemic syndromes, ANS - Cellular & Molecular Mechanisms, and ANS - Systems & Network Neuroscience

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Visual acuity, Population, Visual Acuity, Urology, law.invention, Lesion, Immunoglobulin Fab Fragments, Macular Degeneration, 03 medical and health sciences, 0302 clinical medicine, Atrophy, Double-Blind Method, Randomized controlled trial, law, Settore MED/30, Geographic Atrophy, 80 and over, medicine, Humans, Prospective Studies, Fluorescein Angiography, Prospective cohort study, education, Aged, Original Investigation, Aged, 80 and over, education.field_of_study, business.industry, Middle Aged, Macular degeneration, Complement Factor D, Female, Intravitreal Injections, Treatment Outcome, medicine.disease, Clinical trial, Ophthalmology, 030104 developmental biology, 030221 ophthalmology & optometry, medicine.symptom, business
Abstract

Importance Geographic atrophy (GA) secondary to age-related macular degeneration is a leading cause of visual disability in older individuals. A phase 2 trial suggested that lampalizumab, a selective complement factor D inhibitor, reduced the rate of GA enlargement, warranting phase 3 trials. Objective To assess the safety and efficacy of lampalizumab vs sham procedure on enlargement of GA. Design, Setting, and Participants Two identically designed phase 3 double-masked, randomized, sham-controlled clinical trials, Chroma and Spectri, enrolled participants from August 28, 2014, to October 6, 2016, at 275 sites in 23 countries. Participants were aged 50 years or older, with bilateral GA and no prior or active choroidal neovascularization in either eye and GA lesions in the study eye measuring 2.54 to 17.78 mm 2 with diffuse or banded fundus autofluorescence patterns. Interventions Participants were randomized 2:1:2:1 to receive 10 mg of intravitreous lampalizumab every 4 weeks, sham procedure every 4 weeks, 10 mg of lampalizumab every 6 weeks, or sham procedure every 6 weeks, through 96 weeks. Main Outcomes and Measures Safety and efficacy assessed as mean change from baseline in GA lesion area at week 48 from centrally read fundus autofluorescence images of the lampalizumab arms vs pooled sham arms, in the intent-to-treat population and by complement factor I–profile genetic biomarker. Results A total of 906 participants (553 women and 353 men; mean [SD] age, 78.1 [8.1] years) were enrolled in Chroma and 975 participants (578 women and 397 men; mean [SD] age, 77.9 [8.1] years) were enrolled in Spectri; 1733 of the 1881 participants (92.1%) completed the studies through 48 weeks. The adjusted mean increases in GA lesion area from baseline at week 48 were 1.93 to 2.09 mm 2 across all groups in both studies. Differences in adjusted mean change in GA lesion area (lampalizumab minus sham) were −0.02 mm 2 (95% CI, −0.21 to 0.16 mm 2 ; P = .80) for lampalizumab every 4 weeks in Chroma, 0.16 mm 2 (95% CI, 0.00-0.31 mm 2 ; P = .048) for lampalizumab every 4 weeks in Spectri, 0.05 mm 2 (95% CI, −0.13 to 0.24 mm 2 ; P = .59) for lampalizumab every 6 weeks in Chroma, and 0.09 mm 2 (95% CI, −0.07 to 0.24 mm 2 ; P = .27) for lampalizumab every 6 weeks in Spectri. No benefit of lampalizumab was observed across prespecified subgroups, including by complement factor I–profile biomarker. Endophthalmitis occurred after 5 of 12 447 injections (0.04%) or in 5 of 1252 treated participants (0.4%) through week 48. Conclusions and Relevance In Chroma and Spectri, the largest studies of GA conducted to date, lampalizumab did not reduce GA enlargement vs sham during 48 weeks of treatment. Results highlight the substantial and consistent enlargement of GA, at a mean of approximately 2 mm 2 per year. Trial Registration ClinicalTrials.gov Identifier:NCT02247479andNCT02247531

Published
2018
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3. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: Two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization-verteporfin in photodynamic therapy report 2

Author

Arnold J, Kilmartin D, Olson J, Neville S, Robinson K, Laird A, Richmond C, Farrow A, McKay S, McKechnie R, Evans G, Aaberg TM, Brower J, Waldron R, Loupe D, Gillman J, Myles B, Saperstein DA, Schachat AP, Bressler NM, Bressler SB, Nesbitt P, Porter T, Hawse P, Harnett M, Eager A, Belt J, Cain D, Emmert D, George T, Herring M, McDonald J, Mones J, Corcostegui B, Gilbert M, Duran N, Sisquella M, Nolla A, Margalef A, Miller JW, Gragoudas ES, Lane AM, Emmanuel N, Holbrook A, Evans C, Lord US, Walsh DK, Callahan CD, DuBois JL, Moy J, Kenney AG, Milde I, Platz ES, Lewis H, Kaiser PK, Holody LJ, Lesak E, Lichterman S, Siegel H, Fattori A, Ambrose G, Fecko T, Ross D, Burke S, Conway J, Singerman L, Zegarra H, Novak M, Bartel M, Tilocco DuBois K, Ilc M, Schura S, Joyce S, Tanner V, Rowe P, Smith Brewer S, Greanoff G, Daley G, DuBois J, Lehnhardt D, Kukula D, Fish GE, Jost BF, Anand R, Callanan D, Arceneaux S, Arnwine J, Ellenich P, King J, Aguado H, Rollins R, Anderson T, Nork C, Duignan K, Boleman B, Jurklies B, Pauleikhoff D, Hintzmann A, Fischer M, Sowa C, Behne E, Pournaras CJ, Donati G, Kapetanios AD, Cavaliere K, Guney Wagner S, Gerber N, Sickenberg M, Sickenberg V, Gans A, Hosner B, Sbressa A, Kozma C, Curchod M, Ardoni S, Harding S, Yang YC, Briggs M, Briggs S, Phil EB, Tompkin V, Jackson R, Pearson S, Natha S, Sharp J, Tompkin A, Lim JI, Flaxel C, Padilla M, Levin L, Walonker F, Cisneros L, Nichols T, Schmidt Erfurth U, Barbazetto I, Laqua H, Kupfer R, Bulow R, Glisovic B, Bredfeldt T, Elsner H, Wintzer V, Bahlmann D, Michels S, Gordes R, Neppert B, Grote M, Honnicke K, Blumenkranz MS, Little HL, Jack R, Espiritu LM, Unyi L, Regan J, Lamborn L, Silvestri C, Rosa RH, Rosenfeld PJ, Lewis ML, Rodriguez B, Torres A, Munoz N, Contreras T, Galvez M, Hess D, Cubillas T, Rams I, Slakter JS, Sorenson JA, Bruschi PA, Burke K, Schnipper E, Maranan L, Scolaro M, Riff M, Agresta E, Napoli J, Johansson I, Dedorsson I, Stenkula S, Hvarfner C, Carlsson T, Liljedahl AM, Fallstrom S, Jacobsson E, Hendeberg K, Soubrane G, Kuhn D, Oubraham H, Benelhani A, Kunsch A, Delhoste B, Ziverec G, Lasnier M, Debibie C, Lobes LA, Olsen K, Bahr BJ, Worstell NT, Wilcox LA, Wellman LA, Vagstad G, Steinberg D, Campbell A, Ma C, Dreyer R, Williamson B, Johnson M, Crider H, Anderson H, Brown T, Jelinek K, Graves D, Pope S, Boone R, Beaumont W, Margherio RR, Williams GA, Zajechowski M, Stanley C, Kulak M, Streasick P, Szdlowski L, Falk R, Shoichet S, Regan G, Manatrey P, Cumming K, Fadel R, Mitchel B, Vandell L, Yesestrepsky D, Medina T, Bridges C, Huston G, Koenig F, Benchaboune M, Mezmate K, Fontanay S, Meredith T, Binning J, Gualdoni J, Boyd L, Ort E, Barts B, Allen R, Dahl J, Holle T, Harvey PT, Kaus L, Leuschner D, Bolychuk S, Hewitt I, Voyce J, Menchini U, Virgili G, Lanzetta P, Ambesi M, Pirracchio A, Tedeschi M, Potter MJ, Sahota B, Hall L, Le G, Rai S, Johnson D, Stur M, Lukas J, Tittl M, Docker S, Vogl K, Pieramici DJ, Manos KS, Cooper R, Denbow RL, Lowery ER, Phillips DA, Thibeault SK, Tian Y, Alexander J, Orr PR, Black N, Escartin P, Hartley D, Haworth P, Hecker T, Hiscock D, Jamali F, Maradan N, North J, Norton B, Stapleton Hayes T, Taylor R, Huber G, Deslandes JY, Fsadni M, Hess I, de Pommerol H, Bobillier A, Reaves A, Banasik S, Birch R, Koester J, Stickles R, Truett K, McAlister L, Parker F, Strong HA, Azab M, Buskard N, Gray T, Manjuris U, Hao Y, Su XY, Mason M, Hynes L, Barbezetto I, Birngruber R, Flaxel CJ, Harvey P, Koester JM, Meredith TA, Murphy SA, Strong A, Ulrike M, Beck RW, Bird AC, Coscas G, Deutman A, Jampol L, Klein R, Maguire M, Rosenfeld P, Acreneaux S, Margherio RP, Staflin P, Mones JM, Schmidt Erfurth U., BANDELLO , FRANCESCO, Arnold, J, Kilmartin, D, Olson, J, Neville, S, Robinson, K, Laird, A, Richmond, C, Farrow, A, Mckay, S, Mckechnie, R, Evans, G, Aaberg, Tm, Brower, J, Waldron, R, Loupe, D, Gillman, J, Myles, B, Saperstein, Da, Schachat, Ap, Bressler, Nm, Bressler, Sb, Nesbitt, P, Porter, T, Hawse, P, Harnett, M, Eager, A, Belt, J, Cain, D, Emmert, D, George, T, Herring, M, Mcdonald, J, Mones, J, Corcostegui, B, Gilbert, M, Duran, N, Sisquella, M, Nolla, A, Margalef, A, Miller, Jw, Gragoudas, E, Lane, Am, Emmanuel, N, Holbrook, A, Evans, C, Lord, U, Walsh, Dk, Callahan, Cd, Dubois, Jl, Moy, J, Kenney, Ag, Milde, I, Platz, E, Lewis, H, Kaiser, Pk, Holody, Lj, Lesak, E, Lichterman, S, Siegel, H, Fattori, A, Ambrose, G, Fecko, T, Ross, D, Burke, S, Conway, J, Singerman, L, Zegarra, H, Novak, M, Bartel, M, Tilocco DuBois, K, Ilc, M, Schura, S, Joyce, S, Tanner, V, Rowe, P, Smith Brewer, S, Greanoff, G, Daley, G, Dubois, J, Lehnhardt, D, Kukula, D, Fish, Ge, Jost, Bf, Anand, R, Callanan, D, Arceneaux, S, Arnwine, J, Ellenich, P, King, J, Aguado, H, Rollins, R, Anderson, T, Nork, C, Duignan, K, Boleman, B, Jurklies, B, Pauleikhoff, D, Hintzmann, A, Fischer, M, Sowa, C, Behne, E, Pournaras, Cj, Donati, G, Kapetanios, Ad, Cavaliere, K, Guney Wagner, S, Gerber, N, Sickenberg, M, Sickenberg, V, Gans, A, Hosner, B, Sbressa, A, Kozma, C, Curchod, M, Ardoni, S, Harding, S, Yang, Yc, Briggs, M, Briggs, S, Phil, Eb, Tompkin, V, Jackson, R, Pearson, S, Natha, S, Sharp, J, Tompkin, A, Lim, Ji, Flaxel, C, Padilla, M, Levin, L, Walonker, F, Cisneros, L, Nichols, T, Schmidt Erfurth, U, Barbazetto, I, Laqua, H, Kupfer, R, Bulow, R, Glisovic, B, Bredfeldt, T, Elsner, H, Wintzer, V, Bahlmann, D, Michels, S, Gordes, R, Neppert, B, Grote, M, Honnicke, K, Blumenkranz, M, Little, Hl, Jack, R, Espiritu, Lm, Unyi, L, Regan, J, Lamborn, L, Silvestri, C, Rosa, Rh, Rosenfeld, Pj, Lewis, Ml, Rodriguez, B, Torres, A, Munoz, N, Contreras, T, Galvez, M, Hess, D, Cubillas, T, Rams, I, Slakter, J, Sorenson, Ja, Bruschi, Pa, Burke, K, Schnipper, E, Maranan, L, Scolaro, M, Riff, M, Agresta, E, Napoli, J, Johansson, I, Dedorsson, I, Stenkula, S, Hvarfner, C, Carlsson, T, Liljedahl, Am, Fallstrom, S, Jacobsson, E, Hendeberg, K, Soubrane, G, Kuhn, D, Oubraham, H, Benelhani, A, Kunsch, A, Delhoste, B, Ziverec, G, Lasnier, M, Debibie, C, Lobes, La, Olsen, K, Bahr, Bj, Worstell, Nt, Wilcox, La, Wellman, La, Vagstad, G, Steinberg, D, Campbell, A, Ma, C, Dreyer, R, Williamson, B, Johnson, M, Crider, H, Anderson, H, Brown, T, Jelinek, K, Graves, D, Pope, S, Boone, R, Beaumont, W, Margherio, Rr, Williams, Ga, Zajechowski, M, Stanley, C, Kulak, M, Streasick, P, Szdlowski, L, Falk, R, Shoichet, S, Regan, G, Manatrey, P, Cumming, K, Fadel, R, Mitchel, B, Vandell, L, Yesestrepsky, D, Medina, T, Bridges, C, Huston, G, Koenig, F, Benchaboune, M, Mezmate, K, Fontanay, S, Meredith, T, Binning, J, Gualdoni, J, Boyd, L, Ort, E, Barts, B, Allen, R, Dahl, J, Holle, T, Harvey, Pt, Kaus, L, Leuschner, D, Bolychuk, S, Hewitt, I, Voyce, J, Menchini, U, Bandello, Francesco, Virgili, G, Lanzetta, P, Ambesi, M, Pirracchio, A, Tedeschi, M, Potter, Mj, Sahota, B, Hall, L, Le, G, Rai, S, Johnson, D, Stur, M, Lukas, J, Tittl, M, Docker, S, Vogl, K, Pieramici, Dj, Manos, K, Cooper, R, Denbow, Rl, Lowery, Er, Phillips, Da, Thibeault, Sk, Tian, Y, Alexander, J, Orr, Pr, Black, N, Escartin, P, Hartley, D, Haworth, P, Hecker, T, Hiscock, D, Jamali, F, Maradan, N, North, J, Norton, B, Stapleton Hayes, T, Taylor, R, Huber, G, Deslandes, Jy, Fsadni, M, Hess, I, de Pommerol, H, Bobillier, A, Reaves, A, Banasik, S, Birch, R, Koester, J, Stickles, R, Truett, K, Mcalister, L, Parker, F, Strong, Ha, Azab, M, Buskard, N, Gray, T, Manjuris, U, Hao, Y, Su, Xy, Mason, M, Hynes, L, Barbezetto, I, Birngruber, R, Flaxel, Cj, Harvey, P, Koester, Jm, Meredith, Ta, Murphy, Sa, Strong, A, Ulrike, M, Beck, Rw, Bird, Ac, Coscas, G, Deutman, A, Jampol, L, Klein, R, Maguire, M, Rosenfeld, P, Acreneaux, S, Margherio, Rp, Staflin, P, Mones, Jm, and Schmidt Erfurth, U.

Abstract

PURPOSE: To determine if photodynamic therapy with verteporfin (Visudyne; Novartis AG, Bulach, Switzerland), termed verteporfin therapy, can safely reduce the risk of vision loss compared with a placebo (with sham treatment) in patients with subfoveal choroidal neovascularization caused by age-related macular degeneration who were identified with a lesion composed of occult with no classic choroidal neovascularization, or with presumed early onset classic choroidal neovascularization with good visual acuity letter score, METHODS: This was a double-masked, placebo controlled (sham treatment), randomized, multicenter clinical trial involving 28 ophthalmology practices in Europe and North America. The study population was patients with age related macular degeneration, with subfoveal choroidal neovascularization lesions measuring no greater than 5400 mum in greatest linear dimension with either 1) occult with no classic choroidal neovascularization, best-corrected visual acuity score of at least 50 (Snellen equivalent approximately 20/100), and evidence of hemorrhage or recent disease progression; or 2) evidence of classic choroidal neovascularization with a best-corrected visual acuity score of at least 70 (better than a Snellen equivalent of approximately 20/40); assigned randomly (2:1) to verteporfin therapy or placebo therapy. Verteporfin (6 mg per square meter of body surface area) or placebo (5% dextrose in water) was administered by means of intravenous infusion of 30 mi over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm delivered 50 J/cm(2) by application of an intensity of 600 mW/cm(2) over 83 seconds using a spot size with a diameter 1000 mum larger than the greatest linear dimension of the choroidal neovascularization lesion on the retina. At follow-up examinations every 3 months, retreatment with the same regimen was applied if angiography showed fluorescein leakage. The main outcome measure was at least moderate vision loss, that is, a loss of at least 15 letters (approximately 3 lines), adhering to an intent-to treat analysis with the last observation carried forward to impute for missing data. RESULTS: Two hundred ten (93%) and 193 (86%) of the 225 patients in the verteporfin group compared with 104 (91%) and 99 (87%) of the 114 patients in the placebo group completed the month 12 and 24 examinations, respectively. On average, verteporfin-treated patients received five treatments over the 24 months of follow-up. The primary outcome was similar for the verteporfin-treated and the placebo-treated eyes through the month 12 examination, although a number of secondary visual and angiographic outcomes significantly favored the verteporfin-treated group. Between the month 12 and 24 examinations, the treatment benefit grew so that by the month 24 examination, the vertepor-fin-treated eyes were less likely to have moderate or severe vision loss. Of the 225 verteporfin-treated patients, 121 (54%) compared with 76 (67%) of 114 placebo-treated patients lost at least 15 letters (P =.023). Likewise, 61 of the verteporfin-treated patients (30%) compared with 54 of the placebo-treated patients (47%) lost at least 30 letters (P = .001). Statistically significant results favoring verteporfin therapy at the month 24 examination were consistent between the total population and the subgroup of patients with a baseline lesion composition identified as occult choroidal neovascularization with no classic choroidal neovascularization, This subgroup included 166 of the 225 verteporfin-treated patients (74%) and 92 of the 114 placebo-treated patients (81%). In these patients, 91 of the verteporfin-treated group (55%) compared with 63 of the placebo-treated group (68%) lost at least 15 letters (P =.032), whereas 48 of the verteporfin-treated group (29%) and 43 of the placebo-treated group (47%) lost at least 30 letters (P =.004). Other secondary outcomes, including visual acuity letter score worse than 34 (approximate Snellen equivalent of 20/200 or worse), mean change in visual acuity letter score, development of classic choroidal neovascularization, progression of classic choroidal neovascularization and size of lesion, favored the verteporfin-treated group at both the month 12 and month 24 examination for both the entire study group and the subgroup of cases with occult with no classic choroidal neovascularization at baseline. Subgroup analyses of lesions composed of occult with no classic choroidal neovascularization at baseline suggested that the treatment benefit was greater for patients with either smaller lesions (4 disc areas or less) or lower levels of visual acuity (letter score less than 65, an approximate Snellen equivalent of 20/50(-1) or worse) at baseline. Prospectively planned multivariable analyses confirmed that these two baseline variables affected the magnitude of treatment benefit. Of the 123 verteporfin-treated patients and 64 placebo-heated patients with either visual acuity score Less than 65 or lesion size 4 disc areas or less at baseline, 60 (49%) and 48 (75%) lost at least 15 letters (P < .001), respectively, and 26 (21%) and 31 (48%) lost at least 30 letters (P 2001 by Elsevier Science Inc. All rights reserved.).

Published
2001

4. Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion

Author

Haller, Ja, Bandello, F, Belfort R., Jr, Blumenkranz, M. S., Gillies, M, Heier, J, Loewenstein, A, Yoon, Yh, Jiao, J, Li, Xy, Whitcup, S. M., Aaberg, Tm, Abraham, P, Abujamra, S, Acton, J, Adamczyk Ludyga, A, Adenwalla, M, Agahigian, Dd, Agoas, V, Aguilar Mendoza, M, Aisenbrey, S, Alam, S, Albiani, D, Alexandrescu, B, Alfaiate, Mm, Allam, S, Almeida, Hp, Anagnoste, S, Anand, R, Anderson, N, Antoszyk, A, Armogan, N, Arnold, J, Ash, D, Atlas, Wg, Augustin, Ja, de Ávila MP, Awh, C, Azzolini, C, Babkova, B, Bakri, Sj, Banach, Mj, Barak, A, Barile, G, Barker, D, Barnard, T, Bartz Schmidt KU, Battaglia Parodi, M, Baumal, C, Bedrich, P, Beer, P, Belfort Mattos Junior, R, Bellini, L, Benner, J, Benson, W, Benz, M, Berger, B, Bergren, R, Bharadwaj, A, Bhavan, S, Bhavsar, A, Binder, S, Biondi, A, Bishop, F, Blair, N, Blinder, K, Blumenkranz, M, Bohm, A, Boldrey, Ee, Bornfeld, N, Borrillo, Jl, Boyer, D, Bradford, R, Bridges, W, Brigatti, L, Briggs, M, Brooks HL Jr, Brown, D, Browning, A, Browning, D, Brunner, S, Brunnerova, R, Bryan, Js, Brydak Godowska, J, Buettner, H, Burns, J, Burrows, Af, Busbee, B, Butner, R, Butter, J, Byrnes, G, Callahan, C, Campochiaro, P, Cano Hildalgo RA, Canziani, T, Capaccioli, K, Capone, A, Carmichael, T, Carnevale, K, Casella, Am, Casey, R, Castanheira Dinis, A, Celis, B, Chambers, R, Chang, S, Chang, Yh, Chechik, D, Chee, Sp, Chen, E, Chen, Jt, Chen, Sn, Chen, S, Cheng, B, Chiquet, C, Chong, K, Chong, Lp, Chong, V, Chou, T, Chow, V, Chrapek, O, Chu, T, Chua, J, Chun, D, Chung, Hw, Cialdini, Ap, Ciancas, E, Cihelkova, I, Cisiecki, S, Clark, W, Cleary, T, Coco, R, Codenotti, M, Cohen, Bz, Cohen, Ja, Cohen, J, Connolly, B, Conway, B, Cook, H, Cooper, B, Coors, L, Corwin, J, Costa, Jr, Cottrell, D, Couvillion, S, Craig, J, Cruess, A, Dabbs, T, Danesh, S, Davidorf, F, Davis, J, De Cilla, S, De Fazio, R, de la Fuente MA, de la Rua ER, De Mattia, M, Deen, A, Del Priore, L, Delyfer, Mn, Deuter, C, Devadason, Ds, Devenyi, R, D'Heurle, D, Dickinson, J, Doft, B, Dooner, J, Doubell, D, Downie, J, Drenser, K, Dreyer, R, D'Sousa, Y, Du, T, Duarte, L, Dubiner, Hb, Dubovy, S, Dubska, Z, Dugel, P, Dunn, W, Dusova, J, Dvorak, J, Dyer, D, Dziegielewska, K, Earl, M, Egan, C, Eichenbaum, D, Eifrig, C, Ells, A, El Shabrawi, Y, Elsherbiny, S, Engel, H, Engelbrecht, N, Ernest, J, Essex, R, Eter, N, Evans, R, Fakadej, A, Falcone, P, Fan, D, Fan, Jt, Eid Farah, M, Farah, S, Feiner, L, Feldman, Rm, Ferencz, J, Fernandez Vega Sanz, A, Ferreira, Jl, Figueira, J, Fineman, M, Fiser, I, Fish, G, Fish, Rh, Fishburne, B, Fisher, Sj, Fitzsimons, R, Flaxel, C, Fletcher, E, Flores Aguilar, M, Florez, S, Flynn, H, Fogarty, S, Folgado, A, Foster, Bs, Fox, Gm, Frambach, D, Framme, C, Fransen, S, Fraser Bell, S, Frederick, A, Freeman, W, Freisberg, L, Friedman, E, Friedman, L, Fucik, M, Fuller, Dg, Gaitan, J, Gallemore, R, Gallogly, P, Arumi, Jg, Garg, S, Garretson, B, Gastaud, P, Gaudric, A, Gawrilow, P, Gehlbach, Pl, Geyer, O, Ghuman, At, Giansanti, F, Luiz Gil, A, Gilbert, Hd, Girmens, Jf, Giubilato, A, Glacet Bernard, A, Glaser, D, Glatzer, R, Goldstein, D, Gomes, Am, Gon Yu, H, Gonçalves, Fp, Gonzales, C, Googe, J, Gopal, L, Gordon, A, Gous, P, Grand, M, Cristina, P, Magro, G, Granero Riano, M, Grassi, M, Green, J, Green, S, Gregor, Z, Gregori, N, Grizzard, Ws, Groenewald, C, Gross, Jg, Gross, Ne, Gruber, A, Grutow, G, Guillet, E, Gupta, A, Gyorgyova, D, Haas, A, Haas, K, Hadden, P, Hagemann, L, Hainsworth, D, Haivala, D, Haller, J, Halperin, L, Hamer, P, Hammer, M, Han, D, Handa, Jt, Handelman, I, Handza, J, Harder, B, Harding, S, Hariprasad, Sm, Hartley, K, Hartman, P, Hartnett, Me, Harvey, P, Hassan, T, Headon, M, Hejsek, L, Higgins, P, Hillenkamp, J, Ho, A, Ho, T, Holekamp, N, Holz, E, Holz, F, Hooper, P, Hopkins, Jj, Hoskin Mott, A, Hoskins, J, Hrisomalos, N, Hsu, J, 3rd, Hubbard B., Hudson, H, Hughes, E, Hunt, A, Hunyor, A, Hwang, T, Hwang, Jf, Ibarra, M, Incarnato, N, Inhetvin Hutter, C, Introini, U, Isaacs, T, Islam, N, Iyer, Mn, Jablonski, C, Jack, Rl, Jager, R, Jahn, C, Jao, C, Jehan, F, Jonas, J, Joseph, D, Joshi, M, Jost, B, Jurklies, B, Kaincova, I, Kaiser, P, Kaiser, R, Kalvodova, B, Kamppeter, B, Kanann, Nb, Kang, K, Katz, Rs, Kaushal, S, Kecik, D, Kellaway, J, Kelly, K, Kelly, S, Khan, J, Kherani, A, Kim, R, Kim, I, Kim, J, Kim, Jg, Kim, N, Kim, Tw, Kingsley, R, Klein, R, Klemperer, I, Kociecki, J, Korbasova, M, Korda, V, Korobelnik, Jf, Koshy, Z, Kostamaa, H, Kovach, J, Kozak, I, Kozousek, V, Krasny, J, Kreiger, A, Krivosic, V, Krug JV Jr, Kruger, L, Kunimoto, D, Kuppermann, Bd, Kurtz, R, Kuznik Borkowska, A, Lai, J, Lai, W, Lake, S, Lalwani, G, Lam, Wc, Lanning, Rc, Lanzetta, Paolo, Lara, W, Larrison, Wi, Lattanzio, R, Lavina, A, Lavinsky, J, Lazzaroni, F, Lee, E, Yong Lee, J, Lee, M, Young Lee, S, Lee, V, Leff, S, Lehr, J, Lenfesty, P, Leonard, R, Levine, A, Levitan, M, Lewis, H, Liew, S, Lim, J, Lim, R, Lin, R, Lip, Pl, Liu, J, Lobes, La, Loose, I, Lotery, A, Lottenberg, Cl, Loutchkina, D, Lu, Dw, Lubczynska, A, Lujan, B, Lyssek Boron, A, Ma, C, Ma, P, Maberley, D, Maccumber, M, Madhusudhana, Kc, Madreperla, S, Magee, M, Magolan, J, Maia Junior Ode, O, Maia, A, Majji, A, Malthieu, D, Mango, C, Marmor, M, Marques, L, Martin, D, Martinez, Ja, Massaoutis, P, Mathai, A, Mathur, R, Mattioli, S, Maturi, Rk, Mazur Michalek, I, Mcallister, I, Mccabe, F, Mccannel, Ca, Mcgimpsey, S, Mchugh, Jd, Mckibbin, M, McLean WC Jr, Mcmillan, T, Meireles, R, de Melo CS, Menchini, U, Meredith, T, Merrill, P, Mian, U, Michels, M, Midena, E, Mieler, Wf, Migliavacca, L, Miller, D, Miller, J, Mincey, G, Mitchell, P, Katsuki Mizubuti, S, Mohamed, S, Mohammed, M, Moinfar, N, Moisseiev, J, Mones, J, Montemayor Lobo, R, Montero, J, de Moraes NI, Moreira CA Jr, Morely, M, Moreno, Jm, Moron, Jt, Morrison, Vl, Morse, L, Moshfeghi, A, Moshfeghi, D, Muccioli, C, Munshi, V, Murthy, Rc, Naing, T, Nair, R, Nascimento, J, Nascimento, Vp, Nawrocka, Z, Nawrocki, J, Newell, C, Newsom, R, Nguyen, J, Nguyen, Q, Nguyen, Rl, Nichols, J, Nilanjana, D, Noguchi, B, Noorily, S, Novack, R, Novak, M, Novalis, G, O'Brien, D, Offermann, I, Oguido, Ap, Oh, K, Okruszko, A, de Oliveira TL, Oliver, S, Ong, S, Orellana, J, Orzalesi, N, O'Toole, L, Ovando, Y, Paccione, J, Pach, J, Packo, K, Packowska, Ma, Palmer, J, Palmer, H, Palombi, K, Papp, A, Paques, M, Paranhos A., Jr, Park, D, Park, Ri, Park, S, Parke, D, Parravano, M, Pastor Jimeno JC, Patel, S, Patra, S, Pavan, Pr, Pearce, I, Pecold, K, Pedio, M, Peh, Kk, Pelosini, L, Pendergast, S, Perez, Br, Perez Ortiz DJ, Perkins, S, Peters, M, Pheasant, T, Pilat, J, Pilotto, E, Piltz Seymour, J, Pirracchio, A, Pollack, A, Portella, E, Pracharova, Z, Prati, M, Prensky, Jg, Preston, R, Prieto, F, Puls, S, Purohit, Ar, Quintao, T, Rahhal, F, Rahman, W, Ramos, Ar, Ramsey, S, Rani, A, Rao, Pk, Rapizzi, E, Raskauskas, P, Ratiglia, R, Ratnakaram, R, Rauser, Me, Regillo, C, Rehak, J, Reichel, E, Reid, Da, Rejmont, L, Rougier, Mb, Ribon, Ri, Ricarova, R, Rich, R, Riley, A, Ripandelli, G, Rishi, E, Rivett, K, Rogers, A, Romanet, Jp, Rosa, Pj, Rosberger, D, Rose, S, Rosenfeld, P, Ross, Rr, Rotberg, M, Roth, Cb, Roth, D, Rubaltelli, D, Rubsamen, P, Ruby, A, Ruiz Moreno JM, Ruiz, R, Russell Gonder, J, Russell, M, Ryu, Jw, Sachs, H, Sadda, S, Safar, A, Salinas, C, Sall, K, Samad, A, Samkova, K, Sanders, J, Sandhu, R, Sandhu, Ss, Sandner, D, Sanislo, Sr, Sartani, G, Saviano, S, Savy, O, Schechter, Ba, Schenker, Hi, Schiff, W, Schlichtenbrede, F, Schneider, B, Schneider, L, Schneiderman, T, Schocket, L, Schoenherr, U, Schoenleber, D, Scholl, Hp, Schreiber, J, Schwartz, Sd, Sears, J, Sedlakova, J, Seery, C, Sell, C, Shah, G, Shapiro, M, Sharma, A, Sheidow, T, Sheu, Sj, Sheufele, T, Shukla, D, Siewec Proscinska, J, Silva, Er, Singer, M, Singer, S, Singerman, Lj, Singh, M, Siow, Yc, Sipperley, Jo, Sivaprasad, S, Sjaarda, R, Snyder, W, Sobrin, L, Sodi, A, Solomon, S, Sonkin, P, Soubrane, G, Soucek, P, Spirn, B, Srivastava, S, Stannard, K, Staurenghi, G, Steinmetz, R, Stepien, K, Stern, W, Stevenson, Od, Stewart, D, Stewart, J, Stolba, U, Stoller, G, Stone, C, Stout, Jt, Stringfellow, G, Studnicka, J, Suarez Figueroa, M, Sung, J, Susini, A, Syracuse, R, Szaflik, J, Tabandeh, H, Tadayoni, R, Takahashi, Wy, Taleb, Ac, Talks, Sj, Tamayo, L, Tan, M, Taney, B, Tarnawska, D, Tassinari, G, Taylor, J, Telander, D, Territo, C, Thomas, El, Thomas, M, Thompson, Jt, Thompson, Ws, Tiedeman, Js, Topping, T, Trese, M, Truong, S, Tsang, Cw, Tufail, A, Ufret Vincenty, R, Uhmannova, R, 2nd, Ulanski L., Ulinska, M, Urminsky, J, Uy, H, Vaishnav, H, Varano, M, Vavvas, D, Vega Sanz BF, Veloso, A, Vicha, I, Viola, F, Visser, L, Vlkova, E, Voelker, M, Volkert, D, Vossmerbaumer, U, Vu, C, Vyas, S, Wald, Kj, Walker, J, Walter, A, Wang, R, Wasiak, K, Watt, Dr, Weger, M, 3rd, Weidman F., Weinberger, D, Weisz, Jm, 3rd, Wells J., Wheatley, M, Wickremasingh, S, Wiegand, T, Wieland, M, Will, D, Williams, G, Williams, Rg, Wilson, D, Win, Ph, Wing, Gl, Wirostko, W, Wirthlin, R, Wong, Al, Wong, T, Woo, J, Wu, Tt, Wylegala, E, Yan, J, Yang, Ch, Yang, Cm, Yang, Y, Yang, Yc, Yarian, D, Yates, P, Yedavally, S, Yoken, J, Young, L, Young, S, Zago, Rj, Zakov, Z, Zaras, M, Zegarra, H, Ziemianski, M, Zimmer Galler, I, Zourdani, A, and Zur, C.

Published
2011

5. Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion

Author

Haller, Ja, Bandello, F, Belfort R., Jr, Blumenkranz, Ms, Gillies, M, Heier, J, Loewenstein, A, Yoon, Yh, Jacques, Ml, Jiao, J, Li, Xy, Whitcup, Sm, OZURDEX GENEVA Study Group, Aaberg, Tm, Abraham, P, Abujamra, S, Acton, J, Adamczyk Ludyga, A, Adenwalla, M, Agahigian, Dd, Agoas, V, Aguilar Mendoza, M, Aisenbrey, S, Alam, S, Albiani, D, Alexandrescu, B, Alfaiate, Mm, Allam, S, Almeida, Hp, Anagnoste, S, Anand, R, Anderson, N, Antoszyk, A, Armogan, N, Arnold, J, Ash, D, Atlas, Wg, Augustin, Ja, de Avila MP, Awh, C, Azzolini, C, Babkova, B, Bakri, Sj, Banach, Mj, Barak, A, Barile, G, Barker, D, Barnard, T, Bartz Schmidt KU, Parodi, Mb, Baumal, C, Bedrich, P, Beer, P, Mattos RB Jr, Bellini, L, Benner, J, Benson, W, Benz, M, Berger, B, Bergren, R, Bharadwaj, A, Bhavan, S, Bhavsar, A, Binder, S, Biondi, A, Bishop, F, Blair, N, Blinder, K, Blumenkranz, M, Bohm, A, Boldrey, Ee, Bornfeld, N, Borrillo, Jl, Boyer, D, Bradford, R, Bridges, W, Brigatti, L, Briggs, M, Brooks HL Jr, Brown, D, Browning, A, Browning, D, Brunner, S, Brunnerova, R, Renata, Js, Brydak Godowska, J, Buettner, H, Burns, J, Burrows, Af, Busbee, B, Butner, R, Butter, J, Byrnes, G, Callahan, C, Campochiaro, P, Cano Hildalgo RA, Canziani, T, Capone, A, Carmichael, T, Carnevale, K, Casella, Am, Casey, R, Castanheira Dinis, A, Celis, B, Chambers, R, Chang, S, Chang, Yh, Chechik, D, Chee, Sp, Chen, E, Chen, Jt, Chen, Sn, Chen, S, Cheng, B, Chiquet, C, Chong, K, Chong, Lp, Chong, V, Chou, T, Chow, V, Chrapek, O, Chu, T, Chua, J, Chun, D, Chung, Hw, Cialdini, Ap, Ciancas, E, Cihelkova, I, Cisiecki, S, Clark, W, Cleary, T, Coco, R, Codenotti, M, Cohen, Bz, Cohen, Ja, Cohen, J, Connolly, B, Conway, B, Cook, H, Cooper, B, Coors, L, Corwin, J, Costa, Jr, Cottrell, D, Couvillion, S, Craig, J, Cruess, A, Cupo, G, Dabbs, T, Danesh, S, Davidorf, F, Davis, J, De Cilla, S, De Fazio, R, de la Fuente MA, de la Rua ER, De Mattia, M, Deen, A, Del Priore, L, Delyfer, Mn, Deuter, C, Devadason, Ds, Devenyi, R, D'Heurle, D, Dickinson, J, Doft, B, Dooner, J, Doubell, D, Downie, J, Drenser, K, Dreyer, R, D'Sousa, Y, Du, T, Duarte, L, Dubiner, Hb, Dubovy, S, Dubska, Z, Dugel, P, Dunn, W, Dusova, J, Dvorak, J, Dyer, D, Dziegielewska, K, Earl, M, Egan, C, Eichenbaum, D, Eifrig, C, Ells, A, El Shabrawi, Y, Elsherbiny, S, Engel, H, Engelbrecht, N, Ernest, J, Essex, R, Eter, N, Evans, R, Fakadej, A, Falcone, P, Fan, D, Fan, Jt, Farah, Me, Farah, S, Feiner, L, Feldman, Rm, Ferencz, J, Fernandez Vega Sanz, A, Ferreira, Jl, Figueira, J, Fineman, M, Fiser, I, Fish, G, Fish, Rh, Fishburne, B, Fisher, Sj, Fitzsimons, R, Flaxel, C, Fletcher, E, Flores Aguilar, M, Florez, S, Flynn, H, Fogarty, S, Folgado, A, Foster, Bs, Fox, Gm, Frambach, D, Fransen, S, Fraser Bell, S, Frederick, A, Freeman, W, Freisberg, L, Friedman, E, Friedman, L, Fucik, M, Fuller, Dg, Gaitan, J, Gallemore, R, Gallogly, P, Garcia Arumi, J, Garg, S, Garretson, B, Gastaud, P, Gaudric, A, Gawrilow, P, Gehlbach, Pl, Geyer, O, Ghuman, At, Giansanti, F, Gil, Al, Gilbert, Hd, Girmens, Jf, Giubilato, A, Glacet Bernard, A, Glaser, D, Glatzer, R, Goldstein, D, Gomes, Am, Gon Yu, H, Gonçalves, Fp, Gonzales, C, Googe, J, Gopal, L, Gordon, A, Gous, P, Grand, M, Grandao Magro PC, Granero Riano, M, Grassi, M, Green, J, Green, S, Gregor, Z, Gregori, N, Grizzard, Ws, Groenewald, C, Gross, Jg, Gross, Ne, Gruber, A, Grutow, G, Guillet, E, Gyorgyova, D, Haas, A, Haas, K, Hadden, P, Hagemann, L, Hainsworth, D, Haivala, D, Haller, J, Halperin, L, Hamer, P, Hammer, M, Han, D, Handa, Jt, Handelman, I, Handza, J, Harder, B, Harding, S, Hariprasad, Sm, Hartley, K, Hartman, P, Hartnett, Me, Harvey, P, Hassan, T, Headon, M, Hejsek, L, Higgins, P, Hillenkamp, J, Ho, A, Ho, T, Holekamp, N, Holz, E, Holz, F, Hooper, P, Hopkins, Jj, Hoskin Mott, A, Hoskins, J, Hrisomalos, N, Hsu, J, 3rd, Hubbard B., Hudson, H, Hughes, E, Hunt, A, Hunyor, A, Hwang, T, Hwang, Jf, Ibarra, M, Incarnato, N, Inhetvin Hutter, C, Introini, U, Isaacs, T, Islam, N, Iyer, Mn, Jablonski, C, Jack, Rl, Jager, R, Jahn, C, Jao, C, Jehan, F, Jonas, J, Joseph, D, Joshi, M, Jost, B, Jurklies, B, Kaincova, I, Kaiser, P, Kaiser, R, Kalvodova, B, Kamppeter, B, Kanann, Nb, Kang, K, Katz, Rs, Kaushal, S, Kecik, D, Kellaway, J, Kelly, K, Kelly, S, Khan, J, Kherani, A, Kim, R, Kim, I, Kim, J, Kim, Jg, Kim, N, Kim, Tw, Kingsley, R, Klein, R, Klemperer, I, Kociecki, J, Korbasova, M, Korda, V, Korobelnik, Jf, Koshy, Z, Kostamaa, H, Kovach, J, Kozak, I, Kozousek, V, Krasny, J, Kreiger, A, Krivosic, V, Krug JV Jr, Kruger, L, Kunimoto, D, Kuppermann, Bd, Kurtz, R, Kuznik Borkowska, A, Lai, J, Lai, W, Lake, S, Lalwani, G, Lam, Wc, Lanning, Rc, Lanzetta, Paolo, Lara, W, Larrison, Wi, Lattanzio, R, Lavina, A, Lavinsky, J, Lazzaroni, F, Lee, E, Lee, Jy, Lee, M, Lee, Sy, Lee, V, Leff, S, Lehr, J, Lenfesty, P, Leonard, R, Levine, A, Levitan, M, Lewis, H, Liew, S, Lim, J, Lim, R, Lin, R, Lip, Pl, Liu, J, Lobes, La, Loose, I, Lottenberg, Cl, Loutchkina, D, Lu, Dw, Lubczynska, A, Lujan, B, Lyssek Boron, A, Ma, C, Ma, P, Maberley, D, Maccumber, M, Madhusudhana, Kc, Madreperla, S, Magee, M, Magolan, J, Maia Ode O., Jr, Maia, A, Majji, A, Malthieu, D, Mango, C, Marmor, M, Marques, L, Martin, D, Martinez, Ja, Massaoutis, P, Mathur, R, Mattioli, S, Maturi, Rk, Mazur Michalek, I, Mcallister, I, Mccabe, F, Mccannel, Ca, Mcgimpsey, S, Mchugh, Jd, Mckibbin, M, McLean WC Jr, Mcmillan, T, Meireles, R, de Melo CS, Menchini, U, Meredith, T, Merrill, P, Mian, U, Michels, M, Midena, E, Mieler, Wf, Migliavacca, L, Miller, D, Miller, J, Mincey, G, Mitchell, P, Mizubuti, Sk, Mohamed, S, Mohammed, M, Moinfar, N, Moisseiev, J, Mones, J, Montemayor Lobo, R, Montero, J, de Moraes NI, Moreira CA Jr, Morely, M, Moreno, Jm, Moron, Jt, Morrison, Vl, Morse, L, Moshfeghi, A, Moshfeghi, D, Muccioli, C, Munshi, V, Murthy, Rc, Naing, T, Nair, R, Nascimento, J, Nascimento, Vp, Nawrocka, Z, Nawrocki, J, Newell, C, Newsom, R, Nguyen, J, Nguyen, Q, Nguyen, Rl, Nichols, J, Nilanjana, D, Noguchi, B, Noorily, S, Novack, R, Novak, M, Novalis, G, O'Brien, D, Offermann, I, Oguido, Ap, Oh, K, Okruszko, A, de Oliveira TL, Oliver, S, Ong, S, Orellana, J, Orzalesi, N, O'Toole, L, Ovando, Y, Paccione, J, Pach, J, Packo, K, Packowska, Ma, Palmer, J, Palmer, H, Palombi, K, Papp, A, Paques, M, Paranhos A., Jr, Park, D, Park, Ri, Park, S, Parke, D, Pastor Jimeno JC, Patel, S, Patra, S, Pavan, Pr, Pearce, I, Pecold, K, Pedio, M, Peh, Kk, Pelosini, L, Pendergast, S, Perez, Br, Perez Ortiz DJ, Perkins, S, Peters, M, Pheasant, T, Pilat, J, Pilotto, E, Piltz Seymour, J, Pirracchio, A, Pollack, A, Portella, E, Pracharova, Z, Prati, M, Prensky, Jg, Preston, R, Prieto, F, Puls, S, Purohit, Ar, Quintao, T, Rahhal, F, Rahman, W, Ramos, Ar, Ramsey, S, Rani, A, Rao, Pk, Rapizzi, E, Raskauskas, P, Ratiglia, R, Ratnakaram, R, Rauser, Me, Regillo, C, Rehak, J, Reichel, E, Reid, Da, Rejmont, L, Renaud Rougier MB, Ribon, Ri, Ricarova, R, Rich, R, Riley, A, Ripandelli, G, Rishi, E, Rivett, K, Rogers, A, Romanet, Jp, Rosa, Pj, Rosberger, D, Rose, S, Rosenfeld, P, Ross, Rr, Rotberg, M, Roth, Cb, Roth, D, Rubaltelli, D, Rubsamen, P, Ruby, A, Ruiz Moreno JM, Ruiz, R, Russell Gonder, J, Russell, M, Ryu, Jw, Sachs, H, Sadda, S, Safar, A, Salinas, C, Sall, K, Samad, A, Samkova, K, Sanders, J, Sandhu, R, Sandhu, Ss, Sandner, D, Sanislo, Sr, Sartani, G, Saviano, S, Savy, O, Schechter, Ba, Schenker, Hi, Schiff, W, Schlichtenbrede, F, Schneider, B, Schneider, L, Schneiderman, T, Schocket, L, Schoenherr, Schoenleber, D, Scholl, Hp, Schreiber, J, Schwartz, Sd, Sears, J, Sedlakova, J, Seery, C, Sell, C, Shah, G, Shapiro, M, Sharma, A, Sheidow, T, Sheu, Sj, Sheufele, T, Shukla, D, Siewec Proscinska, J, Silva, E, Singer, M, Singer, S, Singerman, Lj, Singh, M, Siow, Yc, Sipperley, Jo, Sivaprasad, S, Sjaarda, R, Snyder, W, Sobrin, L, Sodi, A, Solomon, S, Sonkin, P, Soubrane, G, Gisèle, P, Spirn, B, Srivastava, S, Stannard, K, Staurenghi, G, Steinmetz, R, Stepien, K, Stern, W, Stevenson, Od, Stewart, D, Stolba, U, Stoller, G, Stone, C, Stout, Jt, Stringfellow, G, Studnicka, J, Suarez Figueroa, M, Sung, J, Susini, A, Syracuse, R, Szaflik, J, Szlechter, M, Tabandeh, H, Tadayoni, R, Takahashi, Wy, Taleb, Ac, Talks, Sj, Tamayo, L, Tan, M, Taney, B, Tarnawska, D, Tassinari, G, Taylor, J, Telander, D, Territo, C, Thomas, M, Thompson, Jt, Thompson, Ws, Tiedeman, Js, Topping, T, Trese, M, Truong, S, Tsang, Cw, Tufail, T, Ufret Vincenty, R, Uhmannova, R, 2nd, Ulanski L., Ulinska, M, Urminsky, J, Uy, H, Vaishnav, H, Varano, M, Vavvas, D, Vega Sanz BF, Veloso, A, Vicha, I, Viola, F, Visser, L, Vlkova, E, Voelker, M, Volkert, D, Vossmerbaumer, U, Vu, C, Vyas, S, Walker, J, Walter, A, Andreas, R, Wasiak, K, Watt, Dr, Weger, M, 3rd, Weidman F., Weinberger, D, Weisz, Jm, 3rd, Wells J., Wheatley, M, Wickremasingh, S, Wiegand, T, Wieland, M, Will, D, Williams, G, Williams, Rg, Wilson, D, Win, Ph, Wing, Gl, Wirostko, W, Wirthlin, R, Wong, Al, Wong, T, Woo, J, Wu, Tt, Wylegala, E, Yan, J, Yang, Ch, Yang, Cm, Yang, Y, Yang, Yc, Yarian, D, Yates, P, Yedavally, S, Yoken, J, Young, L, Young, S, Zago, Rj, Zakov, Z, Zaras, M, Zegarra, H, Ziemianski, M, Zimmer Galler, I, Zourdani, A, and Zur, C.

Published
2010

14. Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin - 1-year results of a randomized clinical trial - VIP report no. 1

Author

Arnold J, Kilmartin D, Olson J, Neville S, Robinson K, Laird A, Richmond C, Farrow A, McKay S, Saperstein DA, Aaberg TM, Johnson JB, Waldron R, Loupe D, Gillman J, Myles B, Schachat AP, Bressler NM, Bressler SB, Nesbitt P, Porter T, Hawse P, Hartnett M, Eager A, Belt J, Cain D, Emmert D, George T, Herring M, McDonald J, Mones J, Corcostegui B, Gilbert M, Duran N, Sisquella M, Nolla A, Margalef A, Miller JW, Gragoudas ES, Lane AM, Emmanuel N, Holbrook A, Evans C, Lord US, Walsh DK, Callahan CD, DuBois JL, Lewis H, Kaiser PK, Holody LJ, Lesak E, Lichterman S, Siegel H, Fattori A, Ambrose G, Fecko T, Ross D, Burke S, Singerman L, Zegarra H, Novak M, Bartel M, Tilocco DuBois K, Iic M, Schura S, Mayes SJ, Tanner V, Rowe P, Smith Brewer S, Kukula D, Greanoff G, Daley G, DuBois J, Lehnhardt D, Fish GE, Jost BF, Anand R, Callanan D, Arceneaux S, Arnwine J, Ellenich P, King J, Aguado H, Rollins R, Jurklies B, Pauleikhoff D, Hintzmann A, Fischer M, Sowa C, Behne E, Pournaras CJ, Donati G, Kapetanios AD, Cavaliere K, Guney Wagner S, Gerber N, Sickenberg M, Sickenberg V, Gans A, Hosner B, Sbressa A, Kozma C, Curchod M, Cancelli SA, Harding S, Yang YC, Briggs M, Briggs S, Tompkin V, Jackson R, Pearson S, Natha S, Sharp J, Lim JI, Flaxel C, Padilla M, Levin L, Walonker F, Cisneros L, Nichols T, Schmidt Erfurth U, Barbazetto I, Laqua H, Kupfer R, Bulow R, Glisovic B, Bredfeldt T, Elsner H, Wintzer V, Bahlmann D, Michels S, Blumenkranz MS, Little HL, Jack R, Espiritu LM, Unyi L, Regan J, Lamborn L, Silvestri C, Rosa RH, Rosenfeld PJ, Lewis ML, Rodriguez B, Torres A, Munoz N, Contreras T, Galvez M, Hess D, Cubillas T, Rams I, Slakter JS, Sorenson JA, Bruschi PA, Burke K, Schnipper E, Maranan L, Scolaro M, Riff M, Agresta E, Johansson I, Dedorsson I, Stenkula S, Hvarfner C, Carlsson T, Liljedahl AM, Fallstrom S, Jacobsson E, Soubrane G, Kuhn D, Oubraham H, Benelhani A, Kunsch A, Delhoste B, Ziverec G, Lasnier M, Lobes LA, Olsen K, Bahr BJ, Worstell NT, Wilcox LA, Wellman LA, Vagstad G, Steinberg D, Campbell A, Dreyer R, Williamson B, Johnson M, Crider H, Margherio RR, Williams GA, Zajechowski M, Stanley C, Kulak M, Streasick P, Szdlowski L, Falk R, Shoichet S, Regan G, Manatrey P, Cumming K, Koenig F, Benchaboune M, Mezmate K, Fontanay S, Meredith T, Binning J, Gualdoni J, Boyd L, Ort E, Barts B, Allen R, Dahl J, Holle T, Harvey PT, Kaus L, Leuschner D, Bolychuk S, Hewitt I, Menchini U, Virgili G, Lanzetta P, Ambesi M, Pirracchio A, Tedeschi M, Potter MJ, Sahota B, Hall L, Stur M, Lukas J, Tittl M, Docker S, Vogl K, Pieramici DJ, Manos KS, Cooper R, Denbow RL, Lowery ER, Phillips DA, Thibeault SK, Tian Y, Harnett M, Black N, Escartin P, Hartley D, Haworth P, Hecker T, Hiscock D, Jamali F, Maradan N, North J, Norton B, Stapleton Hayes T, Taylor R, Huber G, Deslandes JY, Fsadni M, Hess I, de Pommerol H, Bobillier A, Reaves A, Banasik S, Koester J, Gray T, Truett K, Baker J, McAlister L, Birch R, Strong A, Azab M, Buskard N, Manjuris U, Hao Y, Mason M, McCurry U, Birngruber R, Harvey P, Koester JM, Ma C, Murphy SA, Soubrane S, Strong HA, van den Berg H, Beck RW, Bird AC, Coscas G, Deutman A, Jampol L, Klein R, Maguire M, Rosenfeld P, Margherio RP, Staflin P., BANDELLO , FRANCESCO, Arnold, J, Kilmartin, D, Olson, J, Neville, S, Robinson, K, Laird, A, Richmond, C, Farrow, A, Mckay, S, Saperstein, Da, Aaberg, Tm, Johnson, Jb, Waldron, R, Loupe, D, Gillman, J, Myles, B, Schachat, Ap, Bressler, Nm, Bressler, Sb, Nesbitt, P, Porter, T, Hawse, P, Hartnett, M, Eager, A, Belt, J, Cain, D, Emmert, D, George, T, Herring, M, Mcdonald, J, Mones, J, Corcostegui, B, Gilbert, M, Duran, N, Sisquella, M, Nolla, A, Margalef, A, Miller, Jw, Gragoudas, E, Lane, Am, Emmanuel, N, Holbrook, A, Evans, C, Lord, U, Walsh, Dk, Callahan, Cd, Dubois, Jl, Lewis, H, Kaiser, Pk, Holody, Lj, Lesak, E, Lichterman, S, Siegel, H, Fattori, A, Ambrose, G, Fecko, T, Ross, D, Burke, S, Singerman, L, Zegarra, H, Novak, M, Bartel, M, Tilocco DuBois, K, Iic, M, Schura, S, Mayes, Sj, Tanner, V, Rowe, P, Smith Brewer, S, Kukula, D, Greanoff, G, Daley, G, Dubois, J, Lehnhardt, D, Fish, Ge, Jost, Bf, Anand, R, Callanan, D, Arceneaux, S, Arnwine, J, Ellenich, P, King, J, Aguado, H, Rollins, R, Jurklies, B, Pauleikhoff, D, Hintzmann, A, Fischer, M, Sowa, C, Behne, E, Pournaras, Cj, Donati, G, Kapetanios, Ad, Cavaliere, K, Guney Wagner, S, Gerber, N, Sickenberg, M, Sickenberg, V, Gans, A, Hosner, B, Sbressa, A, Kozma, C, Curchod, M, Cancelli, Sa, Harding, S, Yang, Yc, Briggs, M, Briggs, S, Tompkin, V, Jackson, R, Pearson, S, Natha, S, Sharp, J, Lim, Ji, Flaxel, C, Padilla, M, Levin, L, Walonker, F, Cisneros, L, Nichols, T, Schmidt Erfurth, U, Barbazetto, I, Laqua, H, Kupfer, R, Bulow, R, Glisovic, B, Bredfeldt, T, Elsner, H, Wintzer, V, Bahlmann, D, Michels, S, Blumenkranz, M, Little, Hl, Jack, R, Espiritu, Lm, Unyi, L, Regan, J, Lamborn, L, Silvestri, C, Rosa, Rh, Rosenfeld, Pj, Lewis, Ml, Rodriguez, B, Torres, A, Munoz, N, Contreras, T, Galvez, M, Hess, D, Cubillas, T, Rams, I, Slakter, J, Sorenson, Ja, Bruschi, Pa, Burke, K, Schnipper, E, Maranan, L, Scolaro, M, Riff, M, Agresta, E, Johansson, I, Dedorsson, I, Stenkula, S, Hvarfner, C, Carlsson, T, Liljedahl, Am, Fallstrom, S, Jacobsson, E, Soubrane, G, Kuhn, D, Oubraham, H, Benelhani, A, Kunsch, A, Delhoste, B, Ziverec, G, Lasnier, M, Lobes, La, Olsen, K, Bahr, Bj, Worstell, Nt, Wilcox, La, Wellman, La, Vagstad, G, Steinberg, D, Campbell, A, Dreyer, R, Williamson, B, Johnson, M, Crider, H, Margherio, Rr, Williams, Ga, Zajechowski, M, Stanley, C, Kulak, M, Streasick, P, Szdlowski, L, Falk, R, Shoichet, S, Regan, G, Manatrey, P, Cumming, K, Koenig, F, Benchaboune, M, Mezmate, K, Fontanay, S, Meredith, T, Binning, J, Gualdoni, J, Boyd, L, Ort, E, Barts, B, Allen, R, Dahl, J, Holle, T, Harvey, Pt, Kaus, L, Leuschner, D, Bolychuk, S, Hewitt, I, Menchini, U, Bandello, Francesco, Virgili, G, Lanzetta, P, Ambesi, M, Pirracchio, A, Tedeschi, M, Potter, Mj, Sahota, B, Hall, L, Stur, M, Lukas, J, Tittl, M, Docker, S, Vogl, K, Pieramici, Dj, Manos, K, Cooper, R, Denbow, Rl, Lowery, Er, Phillips, Da, Thibeault, Sk, Tian, Y, Harnett, M, Black, N, Escartin, P, Hartley, D, Haworth, P, Hecker, T, Hiscock, D, Jamali, F, Maradan, N, North, J, Norton, B, Stapleton Hayes, T, Taylor, R, Huber, G, Deslandes, Jy, Fsadni, M, Hess, I, de Pommerol, H, Bobillier, A, Reaves, A, Banasik, S, Koester, J, Gray, T, Truett, K, Baker, J, Mcalister, L, Birch, R, Strong, A, Azab, M, Buskard, N, Manjuris, U, Hao, Y, Mason, M, Mccurry, U, Birngruber, R, Harvey, P, Koester, Jm, Ma, C, Murphy, Sa, Soubrane, S, Strong, Ha, van den Berg, H, Beck, Rw, Bird, Ac, Coscas, G, Deutman, A, Jampol, L, Klein, R, Maguire, M, Rosenfeld, P, Margherio, Rp, and Staflin, P.

Subjects
Photomedicine group
Abstract

Objective: To determine if photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, GA) can improve the chance of stabilizing or improving vision (m and best-corrected visual acuity (Snellen equivalent) of approximately 20/100 or better. Intervention: Patients were randomly assigned (2:1) to verteporfin (6 mg per square meter of body surface area; n = 81) or placebo (5% dextrose in water, n = 39) administered via intravenous infusion of 30 ml over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm was delivered at an intensity of 600 mW/cm(2) over 83 seconds to give a light dose of 50 J/cm(2) to a round spot size on the retina with a diameter of 1000 mum larger than the greatest linear dimension of the choroidal neovascular lesion. At follow-up examinations every 3 months, retreatment with either verteporfin or placebo (as assigned at baseline) was applied to areas of fluorescein leakage if present. Main Outcome Measures: The primary outcome was the proportion of eyes at the follow-up examination 12 months after study entry with fewer than eight letters (approximately 1.5 lines) of visual acuity lost, adhering to an intent-to-treat analysis. Results: At baseline, move than 90% of each group had evidence of classic CNV (regardless of whether occult CNV was present) and only 12 (15%) and 5 (13%) cases in the verteporfin and placebo groups, respectively, had occult CNV (regardless of whether classic CNV was present). Seventy-nine of the 81 verteporfin-treated patients (98%) compared with 36 of the 39 placebo-treated patients (92%) completed the month 12 examination. Visual acuity, contrast sensitivity, and fluorescein angiographic outcomes were better in the verteporfin-treated eyes than in the placebo-treated eyes at every follow-up examination through the month 12 examination. At the month 12 examination, 58 (72%) of the verteporfin-treated patients compared with 17 (44%) of the placebo-treated patients lost fewer than eight letters (P < 0.01), including 26 (32%) versus 6 (15%) improving at least five letters (1 line). Seventy (86%) of the verteporfin-treated patients compared with 26 (67%) of the placebo-treated patients lost fewer than 15 letters (P = 0.01), Few ocular or other systemic adverse events were associated with verteporfin therapy compared with placebo treatment. Conclusions: Because photodynamic therapy with verteporfin can safely increase the chance of stabilizing or improving vision in patients with subfoveal CNV from pathologic myopia compared with a placebo, we recommend ophthalmologists consider verteporfin therapy for treatment of such patients. Ophthalmology 2001; 108:841-852 (C) 2001 by the American Academy of Ophthalmology.

17. Two Cases of Chronic Central Serous Chorioretinopathy Successfully Treated with Systemic Interferon Alpha.

Author

Huang L, Flaxel C, Suhler E, and Lin P

Subjects
Humans, Chronic Disease, Male, Middle Aged, Female, Injections, Subcutaneous, Recombinant Proteins therapeutic use, Recombinant Proteins administration & dosage, Adult, Fundus Oculi, Central Serous Chorioretinopathy drug therapy, Central Serous Chorioretinopathy diagnosis, Tomography, Optical Coherence, Interferon-alpha therapeutic use, Fluorescein Angiography, Visual Acuity physiology
Abstract

Chronic central serous chorioretinopathy (CSCR) is a sight threatening disease that can lead to legal blindness. Verteporfin photodynamic therapy is the main treatment for chronic CSCR, however, there has been a critical worldwide shortage of verteporfin. Other medical treatments have been attempted with variable efficacy. Interferons have shown efficacy in treating uveitis and associated macular edema. We report 2 cases of treatment refractory chronic CSCR successfully treated with subcutaneous injection of interferon alpha with significant anatomical and functional improvement. To our knowledge, this is the first report observing the therapeutic potential of systemic interferon alpha in the treatment of chronic CSCR. A large randomized controlled clinical trial would help to better evaluate the safety and efficacy of systemic PEG-IFNα2a in treating chronic CSCR, and further define the optimal dose, treatment interval and duration.

Published
2024
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18. Successful Treatment of Clinically Diagnosed Cancer-Associated Retinopathy with Intravitreal Dexamethasone Implant Followed by 0.18 mg Fluocinolone Implant without Systemic Immunosuppression.

Author

Huang L, Yang P, Flaxel C, Suhler E, and Lin P

Abstract

Purpose: To report a case of clinically diagnosed cancer-associated retinopathy (CAR) successfully treated with intravitreal corticosteroid implants without systemic immunosuppression., Methods: Case report with multimodal imaging., Results: An 80-year-old man without known systemic malignancy presented with debilitating shimmering, hemeralopia and rapidly progressive bilateral vision loss following uncomplicated cataract surgery. Mild vitritis, extensive photoreceptor loss, mottling of retinal pigmentary epithelium (RPE), and mild vascular attenuation were found in both eyes. Full field electroretinogram (ffERG) showed severe bilateral rod-cone dysfunction. Infectious etiologies and vitreoretinal lymphoma were ruled out. During cancer workup, intravitreal corticosteroid treatment was offered. Significant anatomical improvement with reconstitution of ellipsoid zone, improved RPE irregularities and functional improvement, were observed 3 weeks after bilateral intravitreal dexamethasone implants (Ozurdex). 2 months later, patient received bilateral intravitreal 0.18mg fluocinolone acetonide implants (YUTIQ). Later, a colonic adenocarcinoma was found (pathologic stage pT3 pN0). Patient recovered well from surgery and no chemotherapy was needed. 9 months since bilateral intravitreal fluocinolone acetonide implants (11 months since bilateral intravitreal dexamethasone implants), best corrected vision maintained at 20/25-2 OD, 20/20 OS without ongoing treatments. Bilateral reconstitution of ellipsoid zones and nearly resolution of RPE irregularities remained stable. Repeat ffERG demonstrated improved cone response OS and stable diminished rod response OU. Patient reports resolution of ocular symptoms., Conclusion: The sustained improvements with intravitreal corticosteroid monotherapy suggest potential advantages using local therapy over systemic treatment. Long term follow-up is warranted. Further research is needed to evaluate the efficacy of using 0.18mg fluocinolone implant (YUTIQ) to treat CAR., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Opthalmic Communications Society, Inc.)

Published
2024
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19. METformin for the MINimization of Geographic Atrophy Progression (METforMIN): A Randomized Trial.

Author

Shen LL, Keenan JD, Chahal N, Taha AT, Saroya J, Ma CJ, Sun M, Yang D, Psaras C, Callander J, Flaxel C, Fawzi AA, Schlesinger TK, Wong RW, Bryan Leung LS, Eaton AM, Steinle NC, Telander DG, Afshar AR, Neuwelt MD, Lim JI, Yiu GC, and Stewart JM

Abstract

Purpose: Metformin use has been associated with a decreased risk of age-related macular degeneration (AMD) progression in observational studies. We aimed to evaluate the efficacy of oral metformin for slowing geographic atrophy (GA) progression., Design: Parallel-group, multicenter, randomized phase II clinical trial., Participants: Participants aged ≥ 55 years without diabetes who had GA from atrophic AMD in ≥ 1 eye., Methods: We enrolled participants across 12 clinical centers and randomized participants in a 1:1 ratio to receive oral metformin (2000 mg daily) or observation for 18 months. Fundus autofluorescence imaging was obtained at baseline and every 6 months., Main Outcome Measures: The primary efficacy endpoint was the annualized enlargement rate of the square root-transformed GA area. Secondary endpoints included best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) at each visit., Results: Of 66 enrolled participants, 34 (57 eyes) were randomized to the observation group and 32 (53 eyes) were randomized to the treatment group. The median follow-up duration was 13.9 and 12.6 months in the observation and metformin groups, respectively. The mean ± standard error annualized enlargement rate of square root transformed GA area was 0.35 ± 0.04 mm/year in the observation group and 0.42 ± 0.04 mm/year in the treatment group (risk difference = 0.07 mm/year, 95% confidence interval = -0.05 to 0.18 mm/year; P  = 0.26). The mean ± standard error decline in BCVA was 4.8 ± 1.7 letters/year in the observation group and 3.4 ± 1.1 letters/year in the treatment group ( P  = 0.56). The mean ± standard error decline in LLVA was 7.3 ± 2.5 letters/year in the observation group and 0.8 ± 2.2 letters/year in the treatment group ( P  = 0.06). Fourteen participants in the metformin group experienced nonserious adverse events related to metformin, with gastrointestinal side effects as the most common. No serious adverse events were attributed to metformin., Conclusions: The results of this trial as conducted do not support oral metformin having effects on reducing the progression of GA. Additional placebo-controlled trials are needed to explore the role of metformin for AMD, especially for earlier stages of the disease., Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (© 2023 by the American Academy of Ophthalmology.)

Published
2023
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20. Visual Outcomes in Macula-Involving Retinal Detachments Based on Time to Surgical Repair.

Author

Yee C, Xu DN, Berger RF, Traustason KE, and Flaxel C

Subjects
Humans, Retrospective Studies, Scleral Buckling, Visual Acuity, Vitrectomy, Macula Lutea surgery, Retinal Detachment diagnosis, Retinal Detachment surgery
Abstract

Background and Objective: To examine the relationship between duration of macular detachment and postoperative visual acuity in macula-involving rhegmatogenous retinal detachments., Patients and Methods: Retrospective review of patients who underwent surgical repair of macula-involving rhegmatogenous retinal detachments was conducted with Institutional Review Board approval. Primary outcome measure was postoperative best-corrected visual acuity (BCVA) as dependent on duration of macular detachment., Results: In eyes with duration of macular detachment less than or equal to 7 days, postoperative BCVA increased by 0.017 logarithm of the minimum angle of resolution (logMAR) units ( P = .001), and the odds of achieving logMAR 0 decreased by a factor of 0.43 (95% CI, 0.21 to 0.87; P = .02) with each additional day of detachment. Eyes repaired within 3 days of macular detachment were more likely to have postoperative BCVA of logMAR 0 than eyes repaired 4 to 7 days after macular detachment (odds ratio, 2.32; 95% CI, 1.15 to 4.70; P = .02)., Conclusion: Increased duration of macular detachment is associated with progressive decline in postoperative visual acuity. [ Ophthalmic Surg Lasers Imaging Retina 2022;53:439-444.] .

Published
2022
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21. Rationale and Application of the Protocol S Anti-Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy.

Author

Sun JK, Glassman AR, Beaulieu WT, Stockdale CR, Bressler NM, Flaxel C, Gross JG, Shami M, and Jampol LM

Subjects
Adult, Angiogenesis Inhibitors administration & dosage, Clinical Protocols, Diabetic Retinopathy diagnosis, Diabetic Retinopathy physiopathology, Female, Follow-Up Studies, Humans, Intravitreal Injections, Laser Coagulation, Male, Middle Aged, Ranibizumab administration & dosage, Retinal Neovascularization diagnosis, Retinal Neovascularization physiopathology, Vascular Endothelial Growth Factor A antagonists & inhibitors, Visual Acuity, Algorithms, Angiogenesis Inhibitors therapeutic use, Diabetic Retinopathy drug therapy, Ranibizumab therapeutic use, Retinal Neovascularization drug therapy
Abstract

Purpose: To present the rationale, guidelines, and results of ranibizumab treatment for proliferative diabetic retinopathy (PDR) in Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S., Design: Post hoc analyses from a randomized clinical trial., Participants: Three hundred five participants (394 study eyes) having PDR without prior panretinal photocoagulation (PRP)., Methods: Intravitreous ranibizumab (0.5 mg) versus PRP for PDR. Ranbizumab-assigned eyes (n = 191) received monthly injections for 6 months unless resolution was achieved after 4 injections. After 6 months, injections could be deferred if neovascularization was stable over 3 consecutive visits (sustained stability). If neovascularization worsened, monthly treatment resumed. Panretinal photocoagulation could be initiated for failure or futility criteria., Main Outcome Measures: Neovascularization status through 2 years., Results: At 1 month, 19% (35 of 188) of ranibizumab-assigned eyes showed complete neovascularization resolution and an additional 60% (113) showed improvement. At 6 months, 52% (80 of 153) showed neovascularization resolution, 3% (4) were improved, 37% (56) were stable, and 8% (13) had worsened since the last visit. Among eyes with versus without resolved neovascularization at 6 months, the median (interquartile range) number of injections between 6 months and 2 years was 4 (1-7; n = 73) versus 7 (4-11; n = 67; P < 0.001). Injections were deferred in 68 of 73 eyes (93%) meeting sustained stability at least once during the study; 62% (42 of 68) resumed injections within 16 weeks after deferral. At 2 years, 43% (66 of 154) showed neovascularization resolution, 5% (7) showed improvement, 23% (36) were stable, and 27% (42) had worsened since the last visit. Only 3 eyes met criteria for failure or futility through 2 years., Conclusions: The DRCR.net treatment algorithm for PDR can provide excellent clinical outcomes through 2 years for patients initiating anti-vascular endothelial growth factor (VEGF) therapy for PDR. When choosing between anti-VEGF and PRP as first-line therapy for PDR, treatment decisions should be guided by consideration of the relative advantages of each therapeutic method and anticipated patient compliance with follow-up and treatment recommendations., (Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Published
2019
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22. Classification of Choroidal Neovascularization Using Projection-Resolved Optical Coherence Tomographic Angiography.

Author

Patel R, Wang J, Campbell JP, Kiang L, Lauer A, Flaxel C, Hwang T, Lujan B, Huang D, Bailey ST, and Jia Y

Subjects
Aged, Algorithms, Cross-Sectional Studies, Diagnosis, Computer-Assisted, Female, Humans, Macular Degeneration complications, Male, Middle Aged, Reproducibility of Results, Retrospective Studies, Choroidal Neovascularization classification, Tomography, Optical Coherence methods
Abstract

Purpose: To evaluate if projection-resolved optical coherence tomographic angiography (PR-OCTA) reduces projection artifact with less attenuation of choroidal neovascularization (CNV) flow signal compared to conventional OCTA with slab subtraction., Methods: In this retrospective cross-sectional study, participants with subfoveal treatment-naïve CNV secondary to age-related macular degeneration underwent OCTA. Scans were exported for custom processing including manual segmentation as necessary, application of slab subtraction and PR-OCTA algorithm, and calculation of CNV vascular area and connectivity. CNV was classified as type 1, minimally type 2, or predominantly type 2 based on fluorescein angiography (FA) and OCT. Two masked retina specialists independently classified CNV using cross-sectional conventional OCTA and PR-OCTA., Results: A total of 17 eyes were enrolled in this study. Mean CNV vessel area (mm2) was 0.67 ± 0.51 for PR-OCTA and 0.53 ± 0.41 for slab subtraction (P = 0.018). Mean vascular connectivity was 96.80 ± 1.28 for PR-OCTA and 90.90 ± 4.42 (P = 0.018) for slab subtraction. Within-visit repeatability (coefficient of variation) of PR-OCTA was 0.044 for CNV vessel area and 0.012 for vascular connectivity, compared to 0.093 and 0.028 by slab subtraction. PR-OCTA classification agreement with FA/OCT was 88.2% and 76.5% for the two graders, while conventional OCTA agreement was 58.8% and 70.6% (grader 1, P = 0.025; grader 2, P = 0.56). Moreover, PR-OCTA enabled the individual quantification of type 1 and type 2 components of a CNV., Conclusions: PR-OCTA had greater CNV vessel area and vascular connectivity, as well as better repeatability, compared to slab subtraction, suggesting PR-OCTA is a superior technique for imaging CNV. Furthermore, PR-OCTA removes projection artifact on cross-sectional OCTA, improving the ability to classify and quantify CNV components.

Published
2018
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23. Optical coherence tomographic angiography of choroidal neovascularization ill-defined with fluorescein angiography.

Author

Malihi M, Jia Y, Gao SS, Flaxel C, Lauer AK, Hwang T, Wilson DJ, Huang D, and Bailey ST

Subjects
Aged, Aged, 80 and over, Choroid blood supply, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Retrospective Studies, Choroidal Neovascularization diagnostic imaging, Fluorescein Angiography, Tomography, Optical Coherence methods
Abstract

Purpose: To evaluate the morphological structure of ill-defined choroidal neovascularisation (CNV) with traditional fluorescein angiography (FA) compared with optical coherence tomographic angiography (OCTA)., Methods: A retrospective case series study of 11 eyes with ill-defined CNV on FA was performed. Eyes were scanned with commercially available spectral-domain optical coherence tomography (OCT) (70 000 A-scans/s). The split-spectrum amplitude-decorrelation angiography (SSADA) algorithm was used to distinguish blood flow from static tissue. En face OCT angiograms were compared with FA., Results: Eleven cases of ill-defined CNV on FA were identified from 10 study participants. Mean age of the participants was 74.5±6.8 years. Six cases had late leakage from undetermined source (LLUS) and five had fibrovascular pigment epithelial detachment (FVPED). Combining cross-sectional structural OCT with OCT angiograms, all cases were found to have type 1 CNV that corresponded to occult CNV with FA. In all cases of occult CNV on FA, distinct vascular structures were visible with OCTA in the outer retinal/retinal pigment epithelium slab. The mean CNV vessel area was 2.61±3.65 mm 2 . The mean CNV vessel area in cases with FVPED was larger than that in cases with LLUS (4.69±4.72 mm 2 compared with 0.85±0.90 mm 2 , Mann-Whitney p value=0.04)., Conclusions: Although the sample size is small to draw conclusions and the nature of work is retrospective and descriptive, OCTA has the potential to improve visualisation of ill-defined CNV with dye-based angiography, including occult CNV., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Published
2017
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24. Acquired drusenoid deposits on infrared imaging as a sign of vitreoretinal lymphoma.

Author

Campbell JP, Davis S, Flaxel C, Rosenbaum JT, and Lin P

Subjects
Aged, 80 and over, Biopsy, Diagnosis, Differential, Eye Neoplasms complications, Eye Neoplasms diagnosis, Eye Neoplasms surgery, Follow-Up Studies, Humans, Lymphoma, B-Cell complications, Lymphoma, B-Cell surgery, Magnetic Resonance Imaging, Male, Retinal Drusen etiology, Vitrectomy, Vitreous Body surgery, Infrared Rays, Lymphoma, B-Cell diagnosis, Retinal Drusen diagnosis, Retinal Neoplasms complications, Retinal Neoplasms diagnosis, Retinal Neoplasms surgery, Tomography, Optical Coherence methods, Vitreous Body pathology
Published
2014
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25. Prospective randomized controlled trial of combination ranibizumab (Lucentis) and bromfenac (Xibrom) for neovascular age-related macular degeneration: a pilot study.

Author

Flaxel C, Schain MB, Hamon SC, and Francis PJ

Subjects
Aged, Aged, 80 and over, Female, Humans, Intravitreal Injections, Macular Degeneration physiopathology, Male, Middle Aged, Ophthalmic Solutions therapeutic use, Pilot Projects, Prospective Studies, Ranibizumab, Visual Acuity physiology, Angiogenesis Inhibitors therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Benzophenones therapeutic use, Bromobenzenes therapeutic use, Macular Degeneration drug therapy
Abstract

Purpose: To evaluate whether bromfenac eyedrops and ranibizumab intravitreal injections would provide added efficacy over ranibizumab alone., Methods: This was a single-site, multiinvestigator, prospective, open-label, interventional, Phase II study of patients with new or recurrent exudative/neovascular age-related macular degeneration. Thirty eyes were enrolled consecutively and were randomized in a ratio of 2:1 to combination therapy with intravitreal ranibizumab and topical bromfenac, and ranibizumab alone. All patients received ranibizumab monthly therapy for 4 months then as needed monthly in accordance with standard of care. Patients receiving bromfenac self-administered 1 drop twice a day for 12 months. Patients were followed for 12 months., Results: There were no safety concerns with the combination therapy. No statistically significant differences were identified in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity or the number of injections required. However, the mean 12-month change in central macular thickness in the combination group was -81.56 μm while in the ranibizumab group alone the change was -42.50 μm (P = 0.03). The proportion of eyes experiencing a decrease in CMT of 50 μm or more was also significantly higher in those receiving combination therapy (P = 0.046)., Conclusion: This pilot study is the first to prospectively identify a biologic signal that may indicate combination therapy with an easily administered well-tolerated eyedrop and ranibizumab is efficacious for the treatment of neovascular age-related macular degeneration. Further studies are warranted to validate this finding.

Published
2012
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26. Inhibition of choroidal neovascularization in a nonhuman primate model by intravitreal administration of an AAV2 vector expressing a novel anti-VEGF molecule.

Author

Lukason M, DuFresne E, Rubin H, Pechan P, Li Q, Kim I, Kiss S, Flaxel C, Collins M, Miller J, Hauswirth W, Maclachlan T, Wadsworth S, and Scaria A

Subjects
Animals, Enzyme-Linked Immunosorbent Assay, In Situ Hybridization, Intravitreal Injections, Macaca fascicularis, Mice, Mice, Inbred C57BL, Vascular Endothelial Growth Factor Receptor-1 genetics, Choroidal Neovascularization therapy, Dependovirus genetics, Genetic Vectors genetics, Vascular Endothelial Growth Factor A antagonists & inhibitors, Vascular Endothelial Growth Factor Receptor-1 physiology
Abstract

Inhibition of vascular endothelial growth factor (VEGF) for the management of the pathological ocular neovascularization associated with diseases such as neovascular age-related macular degeneration is a proven paradigm; however, monthly intravitreal injections are required for optimal treatment. We have previously shown that a novel, secreted anti-VEGF molecule sFLT01 delivered by intravitreal injection of an AAV2 vector (AAV2-sFLT01) gives persistent expression and is efficacious in a murine model of retinal neovascularization. In the present study, we investigate transduction and efficacy of an intravitreally administered AAV2-sFLT01 in a nonhuman primate (NHP) model of choroidal neovascularization (CNV). A dose-dependent and persistent expression of sFLT01 was observed by collecting samples of aqueous humor at different time points over 5 months. The location of transduction as elucidated by in situ hybridization was in the transitional epithelial cells of the pars plana and in retinal ganglion cells. AAV2-sFLT01 was able to effectively inhibit laser-induced CNV in a dose-dependent manner as determined by comparing the number of leaking CNV lesions in the treated versus control eyes using fluorescein angiography. Our data suggest that intravitreal delivery of AAV2-sFLT01 may be an effective long-term treatment for diseases caused by ocular neovascularization.

Published
2011
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27. Retinal pigment epithelium produces matrix metalloproteinases after laser treatment.

Author

Flaxel C, Bradle J, Acott T, and Samples JR

Subjects
Aged, Blotting, Western, Cell Division, Electrophoresis, Polyacrylamide Gel, Humans, Middle Aged, Organ Culture Techniques, Tissue Inhibitor of Metalloproteinases biosynthesis, Laser Coagulation, Matrix Metalloproteinases biosynthesis, Pigment Epithelium of Eye enzymology, Pigment Epithelium of Eye surgery
Abstract

Purpose: To evaluate production of matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) after panretinal photocoagulation (PRP) of human retinal pigment epithelium (RPE) explants., Methods: Treated explants were subjected to substrate zymography to differentiate MMP-2 from MMP-9 and dot immunoblot analysis to quantify MMP-3 and TIMP activity. Tritiated thymidine uptake by RPE cells was measured to document evidence of cellular division in the laser-treated versus control explants., Results: We detected MMP-2, MMP-3, and TIMP-1. MMP-2 and MMP-3 secretion increased to twice the control values. TIMP decreased until day 4 and then increased by day 6. Tritiated thymidine uptake increased 2.5-fold until day 6, returning to baseline by day 8., Conclusion: PRP disturbs MMP/TIMP balance, inhibiting the initiation and maintenance required for active neovascularization. The efficacy of PRP may be due to changes in the expression pattern of metalloproteinases and inhibitors. This model elucidates the possible contribution of PRP to neovascularization regression by demonstrating the effect of laser on TIMP/MMP balance. The effects of PRP may be much more complex than currently understood and most likely involve more than vascular endothelial growth factor and other ischemia-related factors.

Published
2007
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28. Randomized trial of peribulbar triamcinolone acetonide with and without focal photocoagulation for mild diabetic macular edema: a pilot study.

Author

Chew E, Strauber S, Beck R, Aiello LP, Antoszyk A, Bressler N, Browning D, Danis R, Fan J, Flaxel C, Friedman S, Glassman A, Kollman C, and Lazarus H

Subjects
Combined Modality Therapy, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 2 complications, Diabetic Retinopathy drug therapy, Diabetic Retinopathy surgery, Female, Follow-Up Studies, Glucocorticoids adverse effects, Humans, Injections, Laser Coagulation adverse effects, Macular Edema drug therapy, Macular Edema surgery, Male, Middle Aged, Orbit, Pilot Projects, Prospective Studies, Tomography, Optical Coherence, Treatment Outcome, Triamcinolone Acetonide adverse effects, Visual Acuity, Diabetic Retinopathy therapy, Glucocorticoids therapeutic use, Laser Coagulation methods, Macular Edema therapy, Triamcinolone Acetonide therapeutic use
Abstract

Objective: To provide pilot data on the safety and efficacy of anterior and posterior sub-Tenon injections of triamcinolone either alone or in combination with focal photocoagulation in the treatment of mild diabetic macular edema (DME)., Design: Prospective, phase II, multicenter, randomized clinical trial., Participants: One hundred nine patients (129 eyes) with mild DME and visual acuity 20/40 or better., Methods: The participants were assigned randomly to receive either focal photocoagulation (n = 38), a 20-mg anterior sub-Tenon injection of triamcinolone (n = 23), a 20-mg anterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 25), a 40-mg posterior sub-Tenon injection of triamcinolone (n = 21), or a 40-mg posterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 22). Follow-up visits were performed at 4, 8, 17, and 34 weeks., Main Outcome Measures: Change in visual acuity and retinal thickness measured with optical coherence tomography (OCT)., Results: At baseline, mean visual acuity in the study eyes was 20/25 and mean OCT central subfield thickness was 328 mum. Changes in retinal thickening and in visual acuity were not significantly different among the 5 groups at 34 weeks (P = 0.46 and P = 0.94, respectively). There was a suggestion of a greater proportion of eyes having a central subfield thickness less than 250 mum at 17 weeks when the peribulbar triamcinolone was combined with focal photocoagulation. Elevated intraocular pressure and ptosis were adverse effects attributable to the injections., Conclusions: In cases of DME with good visual acuity, peribulbar triamcinolone, with or without focal photocoagulation, is unlikely to be of substantial benefit. Based on these results, a phase III trial to evaluate the benefit of these treatments for mild DME is not warranted.

Published
2007
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29. Diagnostic and therapeutic challenges.

Author

Reddy S, Roe R, Cunningham ET Jr, Flaxel C, Emerson G, and Ober M

Subjects
Adult, Anti-Bacterial Agents therapeutic use, Antitubercular Agents therapeutic use, Choroid Diseases drug therapy, Drug Therapy, Combination, Eye Infections, Viral drug therapy, Fluorescein Angiography, Glucocorticoids therapeutic use, HIV Infections drug therapy, Humans, Male, Radiography, Thoracic, Retinal Diseases drug therapy, Tomography, X-Ray Computed, Tuberculosis, Miliary drug therapy, Tuberculosis, Ocular drug therapy, Choroid Diseases diagnosis, Eye Infections, Viral diagnosis, HIV Infections diagnosis, Retinal Diseases diagnosis, Tuberculosis, Miliary diagnosis, Tuberculosis, Ocular diagnosis
Published
2006
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30. Visual outcome after silicone oil removal and recurrent retinal detachment repair.

Author

Flaxel CJ, Mitchell SM, and Aylward GW

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Cataract etiology, Cataract Extraction, Child, Female, Glaucoma etiology, Humans, Macula Lutea pathology, Macula Lutea surgery, Male, Middle Aged, Postoperative Complications surgery, Prospective Studies, Recurrence, Reoperation, Retinal Detachment pathology, Treatment Outcome, Retinal Detachment surgery, Silicone Oils therapeutic use, Visual Acuity
Abstract

Purpose: Prospective analysis of the effect of removal of silicone oil (ROSO) in eyes with complicated retinal detachments and evaluation of the visual outcome following recurrent retinal detachment after silicone oil removal., Methods: We evaluated 62 consecutive cases of ROSO over a 12 month period. All eyes had previously undergone silicone oil placement for complicated retinal detachments. All eyes undergoing scheduled ROSO over the time period of the study were entered and were reviewed post-operatively., Results: Sixty-two eyes were entered into the study. Twenty-one of 62 (34%) developed recurrent retinal detachment following ROSO; 18 of these 21 recurrent detachments were reattached with one additional procedure and only 5 required replacement of the silicone oil. Ten of these 21 eyes (48%) had improvement or stabilisation in final visual acuity compared with the presenting visual acuity. Overall, 39 eyes (63%) had improvement in vision following ROSO and 76% of all eyes had ambulatory visual acuity at the end of the follow-up period. Fourteen eyes required cataract extraction with ROSO to attain this final visual acuity., Conclusions: Overall, ROSO has a significant rate of recurrent retinal detachment, with a high reattachment rate with one additional procedure. Few of these eyes need the silicone oil replaced. Most eyes will retain ambulatory visual acuity even with multiple procedures in cases of complicated retinal detachments following ROSO even with recurrent retinal detachment.

Published
2000
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31. Proton beam irradiation of subfoveal choroidal neovascularisation in age-related macular degeneration.

Author

Flaxel CJ, Friedrichsen EJ, Smith JO, Oeinck SC, Blacharski PA, Garcia CA, and Chu HH

Subjects
Aged, Aged, 80 and over, Choroidal Neovascularization etiology, Dose-Response Relationship, Radiation, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Visual Acuity, Choroidal Neovascularization radiotherapy, Macular Degeneration complications, Proton Therapy
Abstract

Purpose: To assess the safety and potential toxicity of proton beam radiation in the treatment of subfoveal choroidal neovascular membrane (CNVM) due to age-related manner degeneration (ARMD) in a prospective, non-randomised study., Methods: Forty-eight eyes of 46 consecutive patients with subfoveal CNVM due to ARMD, not amenable to laser photocoagulation, were treated prospectively with a single proton beam exposure. Two dose regimens were evaluated: 8 CGE (Cobalt Gray Equivalent) and 14 CGE. Patients were followed for an average of 22.1 months after proton beam treatment., Results: At the 12 month follow-up, 44% of eyes in the 8 CGE group and 75% of the eyes in the 14 CGE group had stabilized or improved visual acuity. Complex size in the 8 CGE group as measured on standard fluorescein angiography (FA), decreased or had no change initially but showed less effect over time, while the eyes treated with 14 CGE maintained decreased leakage over the follow-up period of 12 months. However, 11 eyes in the 14 CGE group experienced radiation retinopathy, with the onset between 3 and 30 months. Seven of these 11 eyes have demonstrated some visual loss but only 1 eye developed severe visual loss at 15 months after proton treatment., Conclusions: To date, 14 CGE has suggested a favourable influence on visual function and growth inhibition of CNVM. Proton beam irradiation appears to inhibit CNVM growth. The 14 CGE dose regimen appears to have a longer effect of CNVM growth than does 8 CGE, with overall stabilisation of visual function and growth inhibition. Radiation retinopathy has developed over time, but severe visual loss has been limited. On the basis of the incidence of radiation retinopathy, adjustments in the total radiation dosage and/or fractionation of the dosage should be considered.

Published
2000
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32. North Carolina macular dystrophy (MCDR1) locus: a fine resolution genetic map and haplotype analysis.

Author

Small KW, Udar N, Yelchits S, Klein R, Garcia C, Gallardo G, Puech B, Puech V, Saperstein D, Lim J, Haller J, Flaxel C, Kelsell R, Hunt D, Evans K, Lennon F, and Pericak-Vance M

Subjects
Adolescent, Adult, Child, Child, Preschool, Female, Genetic Linkage, Genetic Markers, Haplotypes, Humans, Infant, Lod Score, Male, Middle Aged, Polymerase Chain Reaction, Chromosomes, Human, Pair 6, Eye Proteins genetics, Macular Degeneration genetics
Abstract

Purpose: We previously reported linkage of North Carolina macular dystrophy in a single isolated family to a broad region on chromosome 6q16. In order to refine the localization of the MCDR1 gene (North Carolina macular dystrophy), additional families with this disease and new markers were studied., Methods: We ascertained 10 families with the North Carolina macular dystrophy phenotype (MCDR1). These families were of various ethnic and geographic origins such as Caucasian, Mayan Indian, African-American, French, British, German, and American of European decent. Two hundred thirty-two individuals in these families underwent comprehensive ophthalmic examinations and blood was collected for genotyping. One hundred seventeen were found to be affected. Linkage simulation studies were performed. Two-point linkage, haplotype analysis, and multipoint linkage was performed using VITESSE and FASTLINK. HOMOG was used to test for genetic heterogeneity., Results: The clinical features were consistent with the diagnosis of North Carolina macular dystrophy in all families. Multipoint linkage analysis indicates that the MCDR1 gene is in the interval between D6D249 and D6S1671 with a maximum LOD score of 41.52. There was no evidence of genetic heterogeneity among the families studied. Families 765, 768, 772, 1193, and 1292 shared the same chromosomal haplotype in this region., Conclusions: This is the largest single data set of families with the MCDR1 phenotype. The single large family from North Carolina continues to be informative for the closest flanking markers and alone supports the minimal candidate region as suggested by previous studies. There remains no evidence of genetic heterogeneity in this disease. Most of the American families appear to have descended from the same ancestral mutation. The remaining families could each represent independent origins of the mutation in the MCDR1 gene.

Published
1999

33. Treatment of pigment epithelial detachments due to age-related macular degeneration with intra-ocular C3F8 injection.

Author

Gross-Jendroska M, Flaxel CJ, Schwartz SD, Holz FG, Fitzke FW, Gabel VP, and Bird AC

Subjects
Aged, Aged, 80 and over, Choroidal Neovascularization diagnosis, Choroidal Neovascularization surgery, Dark Adaptation, Fluorescein Angiography, Follow-Up Studies, Fundus Oculi, Humans, Injections, Laser Coagulation, Middle Aged, Pilot Projects, Posture, Retinal Detachment etiology, Retinal Detachment physiopathology, Visual Acuity, Vitreous Body, Fluorocarbons administration & dosage, Macular Degeneration complications, Retinal Detachment surgery
Abstract

Purpose: To flatten pigment epithelial detachments (PED) due to age-related macular degeneration in an attempt to visualize the underlying choroidal neovascularization by fluorescein angiography (FA) and reveal a treatment target., Methods: Nine patients with PED received intravitreal gas injections via the pars plana and postured face down. Fluorescein angiograms were obtained before and after gas injection. In two patients, retinal scotopic sensitivity was also measured., Results: Eight patients demonstrated change in the shape and size of the PED following gas injection. Four patients showed a better delineation of underlying structures on FA. Three patients had focal laser treatment to the newly visible choroidal neovascular complex, but this was successful in only one patient with flattening of the PED., Conclusion: Pigment epithelial detachments can be modified by intravitreal gas injection in some patients, but this treatment did not have a major impact on overall outcome or management.

Published
1998
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34. Prophylactic laser treatment to fellow eyes of unilateral retinal pigment epithelial tears.

Author

Gross-Jendroska M, Owens SL, Flaxel CJ, Guymer RH, and Bird AC

Subjects
Aged, Aged, 80 and over, Blindness prevention & control, Female, Follow-Up Studies, Fundus Oculi, Humans, Macula Lutea, Male, Middle Aged, Pigment Epithelium of Eye pathology, Prospective Studies, Retinal Perforations etiology, Retinal Perforations pathology, Treatment Outcome, Visual Acuity, Laser Coagulation, Macular Degeneration complications, Pigment Epithelium of Eye surgery, Retinal Drusen complications, Retinal Perforations surgery
Abstract

Purpose: To evaluate prophylactic laser treatment of the macula in reducing the risk of visual loss in the fellow eye of patients with a retinal pigment epithelial tear caused by age-related macular degeneration in the first eye., Methods: In a prospective study, 12 patients with a retinal pigment epithelial tear in one eye caused by age-related macular degeneration and drusen in the fellow eye received prophylactic laser treatment of the retina in their fellow eyes and were followed up for 2 years or more after prophylactic treatment., Results: In 12 fellow eyes that received prophylactic laser treatment, a reduction in best-corrected visual acuity to 20/80 or worse occurred in one (8%) of 12 eyes in the first year and two (18%) of the remaining 11 eyes in the second year after treatment. The cumulative risk of visual loss in the treated fellow eye was 25% in 2 years., Conclusions: In historical control subjects in a natural history study of patients with retinal pigment epithelial tear in one eye, central visual loss occurred in 16 (37%) of 43 eyes in the first year and in seven (30%) of 23 eyes in the second year for a cumulative loss of 59% in the first 2 years. Compared with these historical control subjects, our findings suggest that visual loss in the fellow eyes of patients with a retinal pigment epithelial tear in the first eye is reduced by prophylactic low intensity laser photocoagulation of the macula.

Published
1998
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35. Vitreoretinal surgery after inadvertent globe penetration during local ocular anesthesia.

Author

Wearne MJ, Flaxel CJ, Gray P, Sullivan PM, and Cooling RJ

Subjects
Aged, Aged, 80 and over, Anesthetics, Local, Eye Injuries, Penetrating etiology, Female, Humans, Male, Middle Aged, Needlestick Injuries etiology, Retina injuries, Retinal Detachment etiology, Retinal Detachment surgery, Retrospective Studies, Visual Acuity, Vitreous Hemorrhage etiology, Vitreous Hemorrhage surgery, Anesthesia, Local adverse effects, Eye Injuries, Penetrating surgery, Needlestick Injuries surgery, Orbit injuries, Retina surgery, Vitrectomy
Abstract

Objective: This study aimed to review visual morbidity resulting from inadvertent globe penetration during administration of local anesthetic and to identify the most appropriate management., Design: The records of 20 consecutive patients referred to a specialist vitreoretinal unit over a 2-year period were reviewed., Participants: Twenty eyes of 20 consecutive patients were included., Intervention: Observations included type of local anesthetic administered (e.g., retrobulbar or peribulbar), level of training of person administering the block, type of needle used for the block, and findings at presentation to the vitreoretinal unit. The authors also observed results of B-scan ultrasound evaluation of the retina, interval between the recognition of the complication and referral, as well as nature and timing of subsequent surgical intervention., Main Outcome Measures: Final visual acuity and retinal status (attached versus detached) were measured., Results: The most common presentation was vitreous hemorrhage observed from the first postoperative day. Ten eyes were found to have an associated retinal detachment on initial assessment in the vitreoretinal unit. These eyes generally had a poor visual outcome despite vitrectomy with long-acting gas or silicone oil tamponade. Seven (70%) of the remaining eyes with attached retina at the time of presentation achieved good visual recovery after vitrectomy., Conclusions: The authors recommend prompt referral for consideration of early vitrectomy in eyes with dense vitreous hemorrhage after inadvertent globe penetration. This management may improve the overall visual prognosis by preventing subsequent retinal detachment.

Published
1998
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37. The use of corticosteroids for choroidal neovascularisation in young patients.

Author

Flaxel CJ, Owens SL, Mulholland B, Schwartz SD, and Gregor ZJ

Subjects
Adult, Choroid Diseases complications, Female, Fluorescein Angiography, Follow-Up Studies, Humans, Male, Neovascularization, Pathologic etiology, Neovascularization, Pathologic physiopathology, Prospective Studies, Visual Acuity, Anti-Inflammatory Agents therapeutic use, Choroid blood supply, Glucocorticoids therapeutic use, Neovascularization, Pathologic drug therapy, Prednisolone therapeutic use
Abstract

Purpose: To investigate the role of systemic corticosteroids in the treatment of sight-threatening choroidal neovascularisation (CNV) in patients with punctate inner choroidopathy (PIC) and multifocal inner choroiditis (MIC)., Methods: Twelve eyes of 10 patients with evidence of PIC or MIC with recent visual symptoms were identified. All eyes had CNV within the foveal avascular zone on fundus fluorescein angiography (FFA). Systemic oral prednisolone at an initial dose of 1 mg/kg (60-80 mg) was given for 3-5 days and the dose was subsequently tapered. Changes in best corrected visual acuity and leakage on FFA were recorded during follow-up. Systemic side-effects of the corticosteroids were monitored., Results: In 10 of 12 eyes vision improved or stabilised. Leakage on FFA resolved in 9 eyes and was reduced in 3. Four patients required more than one course of oral corticosteroids. One patient was maintained on low-dose oral corticosteroids for recurrent CNV activity. No systemic complications from the treatment were observed., Conclusion: A course of oral corticosteroids in healthy young patients with subfoveal CNV in PIC or MIC may reduce subretinal vascular leakage and stabilise vision when no other proven treatment option is available.

Published
1998
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40. Peripheral transscleral retinal diode laser for rubeosis iridis.

Author

Flaxel CJ, Larkin GB, Broadway DB, Allen PJ, and Leaver PK

Subjects
Adult, Aged, Aged, 80 and over, Ciliary Body surgery, Female, Humans, Intraocular Pressure, Iris surgery, Male, Middle Aged, Prospective Studies, Sclera, Treatment Outcome, Iris blood supply, Laser Coagulation, Neovascularization, Pathologic surgery, Retina surgery
Abstract

Purpose: To evaluate the results of peripheral transscleral retinal diode photocoagulation with or without transscleral cyclodiode therapy in patients with rubeosis iridis with or without elevated intraocular pressure and no fundal view., Methods: Peripheral transscleral retinal diode photocoagulation was performed in 15 eyes of 13 patients in an attempt to promote regression of rubeosis. The fundus could not be seen in any of the 15 eyes, so conventional panretinal photocoagulation was not possible. Nine eyes had associated elevated intraocular pressure and were treated with concurrent transscleral diode cyclophotocoagulation., Results: All eyes showed regression of rubeosis. Of the nine eyes treated with combination therapy, six had stabilized intraocular pressure, and three developed hypotony. None of the eyes developed a peripheral retinal detachment, and one eye lost the ability to perceive light., Conclusions: This method is effective in treating patients with rubeosis iridis when the view of the fundus is inadequate for conventional panretinal photocoagulation and more extensive intraocular surgery is precluded. It may be combined with transscleral cyclophotocoagulation therapy to manage concurrent high intraocular pressure in rubeotic glaucoma, but this involves a risk of postoperative hypotony.

Published
1997
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41. Partial laser ablation of massive peripapillary subretinal neovascularization.

Author

Flaxel CJ, Bird AC, Hamilton AM, and Gregor ZJ

Subjects
Adult, Aged, Female, Fluorescein Angiography, Fovea Centralis pathology, Fundus Oculi, Humans, Male, Middle Aged, Retinal Neovascularization pathology, Retinal Neovascularization physiopathology, Treatment Outcome, Visual Acuity, Vitreoretinopathy, Proliferative etiology, Vitreoretinopathy, Proliferative pathology, Laser Coagulation, Optic Disk pathology, Optic Disk surgery, Retinal Neovascularization surgery
Abstract

Background: Although peripapillary subretinal neovascular membranes (PSRNs) are less common and often larger than neovascular complexes arising near the fovea, they may lead to severe visual loss. Very large (massive) PSRNs (MPSRNs) are 3.5 disc areas or greater in overall size, are even less common, and may contain a significant occult component, leading to slow and unpredictable growth. Such massive lesions may begin at the nasal margin of the disc and do not become symptomatic until they have extended around the disc toward the macula, threatening central vision. Although complete laser ablation has been used for symptomatic PSRNs with variable success, the optimal treatment of MPSRNs remains controversial., Methods: The authors reviewed the clinical course of 12 eyes of seven patients with MPSRNs. Ten eyes received laser treatment, which was limited to the temporal portion of the subretinal neovascular complexes only and two received no treatment., Results: Of the ten eyes receiving laser treatment, six showed stabilization of visual acuity, whereas in four the neovascular membrane progressed beneath the fovea with severe visual loss. In the two untreated eyes, the subretinal neovascular membrane progressed beneath the macula with the loss of central vision., Conclusions: In contrast to the small symptomatic PSRNs, which are usually treated by complete laser ablation, MPSRNs may stabilize with only partial laser treatment. However, both types of lesions may remain stable for long periods of time without any treatment and require treatment only if progression toward the fovea occurs.

Published
1996
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