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1. Effect of pegaptanib sodium 0.3□mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study

Author

Boyer, David S, Goldbaum, Mauro, Leys, Anita M, Starita, Carla, Blumenkranz, M, Buyse, M, Goldberg, M, Gragoudas, E S, Miller, J, Schwartz, S D, Singerman, L, Yannuzzi, L, Adamis, A P, Guyer, D R, OʼShaughnessy, D, de Gronckel, S, Fesneau, G, Quinaux, E, Tremolet, D, Wang, K, Brailey, A, Finman, J, Ting, N, Bressler, N M, Bressler, S B, Denblow, R, Schein, O D, Seabrook, S, Solomon, S, Schachat, A P, Philips, D, Altaweel, M, Davis, M D, Blodi, B A, Danis, R P, Ip, M S, Hiner, C, Elledge, J, Webster, M, Hannan, C, Ficken, J, Alexander, S, Neider, M, Wabers, H, Vargo, P, Lambert, E, Kastorff, L, Carr, A, Shkiele, A, Baliker, J, Guymer, R, Constable, I, Arnold, J, Sarks, S, Chang, A, Gillies, M, Mitchell, P, Haas, A, Stur, M, Leys, A, Moreira, C, Portella, E, de Avila, M, Taleb, A C, Lavinsky, J, Lavinsky, D, Farah, M E, Williams, G, Leonard, B, Garcia, R, Maberley, D, Lopez, J M, Rodriguez, F J, Fiser, I, Larsen, M, Korobelnik, J-F, Soubrane, G, Koenig, F, Gaudric, A, Dithmar, S, Holz, F G, Joussen, A, Kirchhof, B, Wiedemann, P, Pauleikhoff, D, Schneider, U, Suveges, I, Gyory, J, Pollack, A, Loewenstein, A, Rosenblatt, I, Giovannini, A, Menchini, U, Brancato, R, Piccolino, Cardillo F, Grignolo, F M, Bandello, F, Schlingemann, R O, Deutman, A, Kaluzny, J, Pecold, K, Cunha-Vaz, J, da Silva, R, Ruiz Moreno, J M, Mones, J, Figueroa, M, Pournaras, C, Zografos, L, Lois, N, Chakravarthy, U, Hykin, P, Chisholm, I, Johnson, M W, Marcus, D M, Mandava, N, Haller, J A, Cangemi, F, Boyer, D, Kim, I, Loewenstein, J, Heier, J, Reichel, E, Falcone, P M, Weissgold, D J, Conway, B P, Garfinkel, R, Glaser, B, Lyon, A T, Lewis, H, Wells, J A, Wilcox, L, Fish, G, Eliott, D, Fekrat, S, Taney, B, Eaton, A M, Deramo, V, Wroblewski, J, Tom, D, Chow, D R, Orth, D H, Packo, K H, Holz, E, Mieler, W, Kuppermann, B, Sabates, N, Cummings, H, Pendergast, S D, Gonzales, C, Lim, J I, Charles, S, Sanislo, S, Rosenfeld, P, Connor, T, Cantrill, H, Willson, R, Bailey-Freund, K, Rosen, R, Leonard, R, Brucker, A, Ho, A, Sneed, S, Friberg, T, Klein, M, Tornambe, P, Stoller, G, Capone, A, Jr, Bernstein, P S, McDonald, H R, Schatz, H, Johnson, R N, Nanda, M, Avery, R, Wong, K, Grizzard, W S, Higgins, P, Hudson, H, Joffe, L, Varenhorst, M, Slusher, M M, Betts, F, Cunningham, E, Jr, Curtiss, K, Harrison, E, Katz, B, Masonson, H N, DeMarco, R, Beals, C, Patel, M, Rodriguez, I, and Starita, C

Published
2014
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3. A Multi-Omics Approach Identifies Key Regulatory Pathways Induced by Long-Term Zinc Supplementation in Human Primary Retinal Pigment Epithelium

Author

Emri, E, Kortvely, E, Dammeier, S, Klose, F, Simpson, D, Hollander, AI, Ueffing, M, Lengyel, I, Acar, E, Ajana, S, Arango?gonzalez, B, Armento, A, Badura, F, Bartz?schmidt, U, Biarnes, M, Borrell, A, de Breuk, A, De la Cerda, B, Colijn, Annemarie, Cougnard?gregoire, A, Delcourt, C, Diether, S, Endermann, T, Ferraro, LL, Garcia, M, Heesterbeek, TJ, Honisch, S, Kilger, E, Klaver, Caroline, Langen, H, Meester - Smoor, Magda, Merle, BMJ, Mones, J, Nogoceke, E, Peto, T, Pool, FM, Rodriguez, E, Sousa, J, Thee, Eric, Verzijden, T (Timo), Zumbansen, M, and Ophthalmology

Subjects
0301 basic medicine, proteome, retinal pigment epithelium, lcsh:TX341-641, Biology, medicine.disease_cause, Sensory disorders Donders Center for Medical Neuroscience [Radboudumc 12], Article, Transforming Growth Factor beta1, Transcriptome, Macular Degeneration, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, TGFB1, Cell Adhesion, Electric Impedance, medicine, Humans, Micronutrients, Cell adhesion, age-related macular degeneration, Cells, Cultured, Nutrition and Dietetics, Retinal pigment epithelium, Microvilli, Pigmentation, zinc, Cell Polarity, gene set enrichment, Extracellular Matrix, Cell biology, Oxidative Stress, Protein Transport, secretome, 030104 developmental biology, medicine.anatomical_structure, Secretory protein, Cell culture, Proteome, 030221 ophthalmology & optometry, sense organs, transcriptome, lcsh:Nutrition. Foods and food supply, Oxidative stress, Signal Transduction, Food Science, Extracellular matrix organization
Abstract

In age-related macular degeneration (AMD), both systemic and local zinc levels decline. Elevation of zinc in clinical studies delayed the progression to end-stage AMD. However, the molecular pathways underpinning this beneficial effect are not yet identified. In this study, we used differentiated primary human fetal retinal pigment epithelium (RPE) cultures and long-term zinc supplementation to carry out a combined transcriptome, proteome and secretome analysis from three genetically different human donors. After combining significant differences, we identified the complex molecular networks using Database for Annotation, Visualization and Integrated Discovery (DAVID) and Ingenuity Pathway Analysis (IPA). The cell cultures from the three donors showed extensive pigmentation, development of microvilli and basal infoldings and responded to zinc supplementation with an increase in transepithelial electrical resistance (TEER) (apical supplementation: 443.2 &plusmn, 79.3%, basal supplementation: 424.9 &plusmn, 116.8%, compared to control: 317.5 &plusmn, 98.2%). Significant changes were observed in the expression of 1044 genes, 151 cellular proteins and 124 secreted proteins. Gene set enrichment analysis revealed changes in specific molecular pathways related to cell adhesion/polarity, extracellular matrix organization, protein processing/transport, and oxidative stress response by zinc and identified a key upstream regulator effect similar to that of TGFB1.

Published
2020
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4. Evolving European guidance on the medical management of neovascular age related macular degeneration

Author

Chakravarthy, U., Soubrane, G., Bandello, F., Chong, V., Creuzot-Garcher, C., Dimitrakos, S.A., II, Korobelnik, J.-F., Larsen, M., Mones, J., Pauleikhoff, D., Pournaras, C.J., Staurenghi, G., Virgili, G., and Wolf, S.

Subjects
Macular degeneration -- Care and treatment, Neovascularization -- Care and treatment, Choroid -- Diseases, Ophthalmology -- Practice, Medicine -- Practice, Medicine -- Standards, Health
Published
2006

7. Pathology

Author

Aruin, L. I., Sarkisov, D. S., Lisenco, O. A., O’Connor, H., Cunnane, K., Queiroz, D. M. M., Mendes, E. N., Rocha, G. A., Moura, S. B., Resende, L. M. H., Cunha-Melo, J. R., Carvalho, A. S. T., Coelho, L. G. V., Passos, M. C. G., Castro, L. P., Oliveira, C. A., Lima, G. F., Barbosa, A. J. A., Passos, M. C. F., Castro, P., Testino, Gianni, Perasso, A., Boixeda, D., de Argila, C. Martín, Vila, T., Redondo, C., Cantón, R., Avila, C., Alvarez-Baleriola, I., de Rafael, L., Witteman, E. M., Becx, M. C. J. M., De Koning, R. W., Silva, J. C. P., Nogueira, A. M. M. F., Paulino, E., Miranda, C. R., Rudelli, A., Vialette, G., Sevestre, H., Capron, D., Ducroix, J. P., Smail, A., Baillet, J., Zerbib, F., Seurat, P. L., Sauvet, P., Bechade, D., Rapp, N., Peacock, J. S., Marchildon, P., Zamaniyan, F., Bond-Green, J., Liu, P., Ciota, L., Lee, A., Coltro, N., Chen, M., Alhomsi, M., Adeyemi, E., Goodwin, C. S., Rizzi, C., Maieron, R., Desinan, L., Avellini, C., Da Broi, G. L., Beltrami, C. A., Proto, G., Grimaldi, F., Proietti, A., Scott, C. A., Takasashi, S., Igarshi, H., Ishiyama, N., Nakamura, K., Masubuchi, N., Ozaki, M., Saito, S., Aoyagi, T., Itoh, T., Hirata, I., Matysiak-Budnik, T., Poniewierka, E., Gasciniak, G., Jelen, M., Knapik, Z., Gosciniak, G., Neri, W. M., Susi, D., Bovani, I., Laterza, F., Cuccurullo, F., Amorosi, A., Bechi, P., Dei, R., Mazzanti, R., Lynch, D. A. F., Sobala, G. M., Gledhill, A., Jackson, P., Crabtree, J. E., Foster, P. N., Axon, A. T. R., Dixon, M. F., Maaroos, H. I., Sipponen, P., Kekki, M., Di Bello, M. G., Raspanti, S., Vardar, T., Sancho F. J., Olivia E., Saiz S., Mones J. Pons, Hood, Craig, Lesna, Milena, Alcolado, Ruth, Knitht, T., Greaves, S., Wilson, A., Corlett, M., Webb, P., Wyatt, J., Newell, D., Hengels, K., Forman, D., Elder, J. B., Farinati, F., Cardin, R., Valiante, F., Libera, G. Delia, Plebani, M., Rugge, M., Baffa, R., Guido, M., Mario, F. Di, Naccarato, R., Gilvarry, J., Leen, E., Sant, S., Sweeney, E., Morain, C. O’, Schönlebe, J., Riedel, H., Prinz, M., Hahn, L., Porst, H., Lohmann, H., Orsini, E., Guerre, J., Tulliez, M., Chaussade, S., Gaudric, M., Canton, R., Sampedro, J., García-Plaza, A., Cognein, P., Parodi, M. C., Tucci, A., Gasperoni, S., Stanghellini, V., Tosetti, C., Paparo, G. F., Varoli, O., Siringo, S., Santucci, R., Monetti, N., Barbara, G., Corinaldesi, R., Di Mario, F., Dotto, P., Vianello, F., M. Ferrana, Grasso, G. A., Bianco, T. Del, Laino, G., Germanà, B., Battaglia, G, Axelson, C. K., Andersen, L. P., Szecsi, P. B., Olsen, K. N., Lundborg, C. J., Andre, C., Descos, L., Martin, A., Cavagna, S., Brassens-Rabbé, M P., Wu, S., Wadström, T., Mégraud, F., Perdichizzi, G., Muratori, L., Pallio, S., Bottair, M., T. Fera, M., Quattrocchi, E., Caruso, V., Karttunen, T., Kerola, T., Kartttunen, R., Niemelä, S., Kosunen, T. U., Bonchviam, F., Pretolani, S., Baraldine, M., Cilla, D., Baldinelli, S., and Gasparrini, G.

Published
1992
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8. Mediterranean Diet and Incidence of Advanced Age-Related Macular Degeneration: The EYE-RISK Consortium

Author

Merle, B.M.J., Colijn, J.M., Cougnard-Gregoire, A., Koning-Backus, A.P.M. de, Delyfer, M.N., Kiefte-de Jong, J.C., Meester-Smoor, M., Feart, C., Verzijden, T., Samieri, C., Franco, O.H., Korobelnik, J.F., Klaver, C.C.W., Delcourt, C., Ajana, S., Arango-Gonzalez, B., Armento, A., Arndt, V., Bhatia, V., Bhattacharya, S.S., Biarnes, M., Borrell, A., Buhren, S., Calado, S.M., Dammeier, S., Jong, E.K. de, Cerda, B. de la, Hollander, A.I. den, Diaz-Corrales, F.J., Diether, S., Emri, E., Endermann, T., Ferraro, L.L., Garcia, M., Heesterbeek, T.J., Honisch, S., Hoyng, C.B., Kersten, E., Kilger, E., Langen, H., Lengyel, I., Luthert, P., Maugeais, C., Mones, J., Nogoceke, E., Peto, T., Pool, F.M., Rodriguez, E., Ueffing, M., Bartz-Schmidt, K.U.U., Leeuwen, E.M. van, Zumbansen, M., Vasiliev, V., and EYE-RISK Consortium

Published
2019

9. Increased High-Density Lipoprotein Levels Associated with Age-Related Macular Degeneration Evidence from the EYE-RISK and European Eye Epidemiology Consortia

Author

Colijn, J.M., Hollander, A.I. den, Demirkan, A., Cougnard-Gregoire, A., Verzijden, T., Kersten, E., Meester-Smoor, M.A., Merle, B.M.J., Papageorgiou, G., Ahmad, S., Mulder, M.T., Costa, M.A., Benlian, P., Bertelsen, G., Bron, A.M., Claes, B., Creuzot-Garcher, C., Erke, M.G., Fauser, S., Foster, P.J., Hammond, C.J., Hense, H.W., Hoyng, C.B., Khawaja, A.P., Korobelnik, J.F., Piermarocchi, S., Segato, T., Silva, R., Souied, E.H., Williams, K.M., Duijn, C.M. van, Delcourt, C., Klaver, C.C.W., Acar, N., Altay, L., Anastosopoulos, E., Azuara-Blanco, A., Berendschot, T., Bergen, A., Binquet, C., Bird, A., Bobak, M., Larsen, M.B., Boon, C., Bourne, R., Bretillon, L., Broe, R., Bron, A., Buitendijk, G., Cachulo, M.L., Capuano, V., Carriere, I., Chakravarthy, U., Chan, M., Chang, P., Colijn, J., Cree, A., Cumberland, P., Cunha-Vaz, J., Daien, V., Jong, E. de, Deak, G., Delyfer, M.N., Hollander, A. den, Dietzel, M., Faria, P., Farinha, C., Finger, R., Fletcher, A., Foster, P., Founti, P., Gorgels, T., Grauslund, J., Grus, F., Hammond, C., Heesterbeek, T., Hermann, M., Hoehn, R., Hogg, R., Holz, F., Hoyng, C., Jansonius, N., Janssen, S., Khawaja, A., Klaver, C., Lamparter, J., Goff, M. le, Lehtimaki, T., Leung, I., Lotery, A., Mauschitz, M., Meester, M., Merle, B., Westrup, V.M.Z., Midena, E., Miotto, S., Mirshahi, A., Mohan-Said, S., Mueller, M., Muldrew, A., Murta, J., Nickels, S., Nunes, S., Owen, C., Peto, T., Pfeiffer, N., Prokofyeva, E., Rahi, J., Raitakari, O., Rauscher, F., Ribeiro, L., Rougier, M.B., Rudnicka, A., Sahel, J., Salonikiou, A., Sanchez, C., Schick, T., Schmitz-Valckenberg, S., Schuster, A., Schweitzer, C., Shehata, J., Silvestri, G., Simader, C., Souied, E., Speckauskas, M., Springelkamp, H., Tapp, R., Topouzis, F., Leeuwen, E. van, Verhoeven, V., Vingerling, H., Hanno, T. von, Williams, K., Wolfram, C., Yip, J., Zerbib, J., Ajana, S., Arango-Gonzalez, B., Arndt, V., Bhatia, V., Bhattacharya, S.S., Biarnes, M., Borrell, A., Buhren, S., Calado, S.M., Dammeier, S., Jong, E.K. de, Cerda, B. de la, Diaz-Corrales, F.J., Diether, S., Emri, E., Endermann, T., Ferraro, L.L., Garcia, M., Heesterbeek, T.J., Honisch, S., Kilger, E., Langen, H., Lengyel, I., Luthert, P., Maugeais, C., Meester-Smoor, M., Inserm, B.M.J.M., Mones, J., Nogoceke, E., Pool, F.M., Rodriguez, E., Ueffing, M., Bartz-Schmidt, K.U.U., Leeuwen, E.M. van, Zumbansen, M., European Eye Epidemiology Consorti, and EYE-RISK Consortium

Published
2019

10. 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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13. Individualized Ranibizumab Regimen Driven by Stabilization Criteria for Central Retinal Vein Occlusion

Author

Larsen, M., Waldstein, S.M., Boscia, F., Gerding, H., Mones, J., Tadayoni, R., Priglinger, S., Wenzel, A., Barnes, E., Pilz, S., Stubbings, W., Pearce, I., and CRYSTAL Study Grp

Subjects
medicine.medical_specialty, education.field_of_study, Visual acuity, genetic structures, business.industry, Population, medicine.disease, eye diseases, Surgery, 03 medical and health sciences, Regimen, Ophthalmology, 0302 clinical medicine, Central retinal vein occlusion, Pro re nata, 030221 ophthalmology & optometry, medicine, Ranibizumab, medicine.symptom, business, education, Prospective cohort study, Macular edema, 030217 neurology & neurosurgery, medicine.drug
Abstract

Purpose To assess the 12-month efficacy and safety profile of an individualized regimen of ranibizumab 0.5 mg driven by stabilization criteria in patients with macular edema secondary to central retinal vein occlusion (CRVO). Design A 24-month, prospective, open-label, single-arm, multicenter study. Participants Three hundred fifty-seven patients. Methods Patients were treated with monthly ranibizumab 0.5-mg injections (minimum of 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg was dosed as needed if monthly monitoring indicated a loss of VA resulting from disease activity. Main Outcome Measures Mean change from baseline at month 12 in best-corrected VA (BCVA; primary end point) and safety over 12 months. The efficacy of this regimen in subgroups categorized by baseline BCVA score, CRVO duration, or presence of macular ischemia (exploratory analysis). Results At baseline, the mean BCVA was 53.0 letters and mean CRVO duration was 8.9 months (median, 2.4 months). Ranibizumab 0.5-mg treatment resulted in a statistically significant mean gain in BCVA from baseline at month 12 of 12.3 letters (standard deviation [SD], 16.72 letters; P Conclusions An individualized dosing regimen of ranibizumab 0.5 mg driven by stabilization criteria for up to 12 months resulted in significant BCVA gain in a broad population of patients with macular edema secondary to CRVO, including those with macular ischemia at baseline. The safety findings were consistent with those reported in previous ranibizumab studies in patients with CRVO.

Published
2016

14. 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

16. 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, 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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, 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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

17. 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

20. Bimonthly half-dose ranibizumab in large pigment epithelial detachment and retinal angiomatous proliferation with high risk of retinal pigment epithelium tear: a case report

Author

Monés J, Biarnés M, and Badal J

Subjects
Ophthalmology, RE1-994
Abstract

Jordi Monés,1,2 Marc Biarnés,1 Josep Badal11Institut de la Màcula i de la Retina, Barcelona, Spain; 2Barcelona Macula Foundation, Barcelona, SpainIntroduction: The management of large pigment epithelial detachments (PEDs) associated with retinal angiomatous proliferation (RAP) remains a challenge due to the high risk of retinal pigment epithelial (RPE) tear. We describe the successful progressive anatomical result and the maintenance of visual acuity to bimonthly, half-dose ranibizumab in a patient with this condition.Purpose: To describe the management of a large PED secondary to RAP with bimonthly, half-dose ranibizumab.Method: Case report.Patient: A 71-year-old woman presented with visual symptoms due to an enlarged PED, compared with previous visits, secondary to a RAP lesion, with a visual acuity of 20/32. To reduce the risk of an RPE tear and a significant decrease in vision, we discussed with the patient the possibility of treating the lesion in a progressive manner, with more frequent but smaller doses of ranibizumab. The patient was treated biweekly with 0.25 mg of ranibizumab until flattening of the PED.Results: The large PED flattened progressively, and visual acuity was preserved with no adverse events.Discussion: The use of half-dose antiangiogenic therapy may be useful in managing large vascularized PED associated with RAP, in an attempt to reduce the risk of RPE tear.Keywords: age-related macular degeneration, pigment epithelial detachment, ranibizumab, retinal angiomatous proliferation, RPE tear

Published
2013

23. Non-neovascular age-related macular degeneration with subretinal fluid

Author

Frederic Gunnemann, Riccardo Sacconi, Giuseppe Querques, Mee Yon Lee, Abdallah A. Ellabban, Dinah Zur, Jordi Monés, Sengul Ozdek, Srinivas R. Sadda, Won Ki Lee, K. Bailey Freund, Daniel Pauleikhoff, Michael S. Ip, Assaf Hilely, Usha Chakravarthy, Adrian Au, Nadia K Waheed, Claudio Iovino, Eric H Souied, Yoshimi Sugiura, Albrecht Lommatzsch, Frank G. Holz, Enrico Borrelli, Luísa S.M. Mendonça, Anat Loewenstein, Richard F. Spaide, Duygu Yalinbas, Meryem Filali Ansary, Pierre Turcotte, Sarah Thiele, Enrico Peiretti, David Sarraf, Vittorio Capuano, Hilely, A., Au, A., Freund, K. B., Loewenstein, A., Souied, E. H., Zur, D., Sacconi, R., Borrelli, E., Peiretti, E., Iovino, C., Sugiura, Y., Ellabban, A. A., Mones, J., Waheed, N. K., Ozdek, S., Yalinbas, D., Thiele, S., De Moura Mendonca, L. S., Lee, M. Y., Lee, W. K., Turcotte, P., Capuano, V., Filali Ansary, M., Chakravarthy, U., Lommatzsch, A., Gunnemann, F., Pauleikhoff, D., Ip, M. S., Querques, G., Holz, F. G., Spaide, R. F., Sadda, S., and Sarraf, D.

Subjects
Vascular Endothelial Growth Factor A, medicine.medical_specialty, genetic structures, Visual Acuity, Angiogenesis Inhibitors, Retinal Drusen, Drusen, Retina, Cellular and Molecular Neuroscience, chemistry.chemical_compound, Macular Degeneration, Optical coherence tomography, Ophthalmology, medicine, Humans, Decompensation, Fluorescein Angiography, Retrospective Studies, medicine.diagnostic_test, business.industry, Choroid, Subretinal Fluid, Macula, Retinal Detachment, Retinal, Macular degeneration, medicine.disease, Sensory Systems, eye diseases, Angiogenesi, medicine.anatomical_structure, chemistry, Intravitreal Injections, Wet Macular Degeneration, Degeneration, sense organs, Subretinal fluid, business, Retinal Pigments, Tomography, Optical Coherence, Follow-Up Studies
Abstract

PurposeTo evaluate the various patterns of subretinal fluid (SRF) in eyes with age-related macular degeneration (AMD) in the absence of macular neovascularisation (MNV) and to assess the long-term outcomes in these eyes.MethodsThis retrospective study included only eyes with non-neovascular AMD and associated SRF. Eyes with evidence of MNV were excluded. Spectral-domain optical coherence tomography (SD-OCT) was obtained at baseline and at follow-up, and qualitative and quantitative SD-OCT analysis of macular drusen including drusenoid pigment epithelial detachment (PED) and associated SRF was performed to determine anatomic outcomes.ResultsForty-five eyes (45 patients) were included in this analysis. Mean duration of follow-up was 49.7±36.7 months. SRF exhibited three different morphologies: crest of fluid over the apex of the drusenoid PED, pocket of fluid at the angle of a large druse or in the crypt of confluent drusen or drape of low-lying fluid over confluent drusen. Twenty-seven (60%) of the 45 eyes with fluid displayed collapse of the associated druse or drusenoid PED and 24 (53%) of the 45 eyes developed evidence of complete or incomplete retinal pigment epithelial and outer retinal atrophy.ConclusionNon-neovascular AMD with SRF is an important clinical entity to recognise to avoid unnecessary anti-vascular endothelial growth factor therapy. Clinicians should be aware that SRF can be associated with drusen or drusenoid PED in the absence of MNV and may be the result of retinal pigment epithelial (RPE) decompensation and RPE pump failure.

Published
2021

24. Undertreatment of Neovascular Age-Related Macular Degeneration after 10 Years of Anti-Vascular Endothelial Growth Factor Therapy in the Real World: The Need for A Change of Mindset

Author

Jordi Monés, Richard Gale, Rishi P Singh, Xin Liu, Eric H Souied, Francesco Bandello, Mones, J., Singh, R. P., Bandello, F., Souied, E., Liu, X., and Gale, R.

Subjects
Treatment burden, Vascular Endothelial Growth Factor A, medicine.medical_specialty, Visual acuity, Poor compliance, Undertreatment, Visual Acuity, Mindset, Angiogenesis Inhibitors, 01 natural sciences, 03 medical and health sciences, 0302 clinical medicine, Age related, Ranibizumab, medicine, Humans, 0101 mathematics, Intensive care medicine, business.industry, 010102 general mathematics, Anti-VEGF, General Medicine, Macular degeneration, medicine.disease, Sensory Systems, Virtuous circle and vicious circle, Clinical trial, Ophthalmology, Anti–vascular endothelial growth factor therapy, Treatment Outcome, Intravitreal Injections, 030221 ophthalmology & optometry, Wet Macular Degeneration, medicine.symptom, business, Neovascular age-related macular degeneration
Abstract

Purpose: To assess the gap between visual acuity (VA) outcomes with anti-vascular endothelial growth factor (anti-VEGF) therapies in clinical trials and real-world practice, and explore the reasons for this gap. Methods: The literature was searched from January 1, 2013, to June 30, 2018, for studies reporting VA gains and injection frequencies in clinical trials and real-world practice. Results: Clinical trials of anti-VEGF agents and their extension studies demonstrated initial VA gains maintained at 4 years and beyond (up to 7 years) with continuous proactive treatment. Visual outcomes correlated with injection frequency. In real-world practice, patients are usually undertreated, accounting for the VA decline over time. Reasons for undertreatment include the burden of injections and monitoring visits imposed on patients/caregivers. However, another primary reason is the general mindset in the ophthalmological community that sustained benefits with treatment are not possible, leading to poor compliance and creating a vicious circle. Conclusions: Initial VA gains can be maintained with more intensive/proactive approaches. Promising new treatments requiring less frequent injections/monitoring will help in the near future; meanwhile, better results could be achieved by changing the community mindset that contributes to undertreatment.

Published
2020

26. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA)

Author

Michael Larsen, Gisbert Richard, Ursula Schmidt-Erfurth, Eric H Souied, Jordi Monés, Bora Eldem, Francesco Bandello, Anat Loewenstein, Victor Chong, Reinier O. Schlingemann, Schmidt Erfurth, U, Chong, V, Loewenstein, A, Larsen, M, Souied, E, Schlingemann, R, Eldem, B, Mones, J, Richard, G, and Bandello, Francesco

Subjects
Vascular Endothelial Growth Factor A, medicine.medical_specialty, genetic structures, Angiogenesis Inhibitors, Review, Disease, Light Coagulation, Retina, Cellular and Molecular Neuroscience, Quality of life (healthcare), Ophthalmology, Health care, medicine, Humans, Disease management (health), Intensive care medicine, Evidence-Based Medicine, business.industry, Public health, Macular degeneration, medicine.disease, Medical research, Choroidal Neovascularization, eye diseases, Sensory Systems, Wet Macular Degeneration, Life expectancy, sense organs, business, Tomography, Optical Coherence
Abstract

UNLABELLED: Age-related macular degeneration (AMD) is still referred to as the leading cause of severe and irreversible visual loss world-wide. The disease has a profound effect on quality of life of affected individuals and represents a major socioeconomic challenge for societies due to the exponential increase in life expectancy and environmental risks. Advances in medical research have identified vascular endothelial growth factor (VEGF) as an important pathophysiological player in neovascular AMD and intraocular inhibition of VEGF as one of the most efficient therapies in medicine. The wide introduction of anti-VEGF therapy has led to an overwhelming improvement in the prognosis of patients affected by neovascular AMD, allowing recovery and maintenance of visual function in the vast majority of patients. However, the therapeutic benefit is accompanied by significant economic investments, unresolved medicolegal debates about the use of off-label substances and overwhelming problems in large population management. The burden of disease has turned into a burden of care with a dissociation of scientific advances and real-world clinical performance. Simultaneously, ground-breaking innovations in diagnostic technologies, such as optical coherence tomography, allows unprecedented high-resolution visualisation of disease morphology and provides a promising horizon for early disease detection and efficient therapeutic follow-up. However, definite conclusions from morphologic parameters are still lacking, and valid biomarkers have yet to be identified to provide a practical base for disease management. The European Society of Retina Specialists offers expert guidance for diagnostic and therapeutic management of neovascular AMD supporting healthcare givers and doctors in providing the best state-of-the-art care to their patients. TRIAL REGISTRATION NUMBER: NCT01318941.

Published
2014

27. Use of Asynchronous Interprofessional e-Consults in Cancer Patients During the COVID-19 Pandemic: Current and Future Role.

Author

Gordon A, Rotemberg V, Love D, Kurtansky NR, Pagel D, and Mones J

Subjects
Humans, Pandemics, Referral and Consultation, Delivery of Health Care, COVID-19, Telemedicine, Neoplasms
Abstract

The COVID-19 pandemic created a unique challenge to health care systems, requiring rapid implementation of telemedicine services to provide continued care to patients while preserving personal protective equipment and decreasing the risk of disease transmission. Herein, we describe how our institution, an urban cancer center, utilized provider-to-provider telemedicine consultations (interprofessional e-consults) to provide subspecialty access to care to vulnerable patients in the epicenter of a global pandemic.

Published
2023
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28. ISOPT Clinical Hot Topic Panel Discussion on Medical Treatment of Retinal Diseases.

Author

Kuppermann BD, Bernstein P, Mones J, Do DV, Neumann R, and Rosenfeld PJ

Subjects
Drug Delivery Systems, Humans, Retinal Diseases metabolism, Drug Design, Retinal Diseases drug therapy, Vascular Endothelial Growth Factor A antagonists & inhibitors
Abstract

Topics change as time flows. This is especially true in retinal therapeutics that merely 25 years ago was mainly a surgical field and in two decades has been transformed into a classic pharmacologic medical field. That said, the classic questions of pharmacology such as pharmacokinetics, pharmacodynamics, dosing and delivery systems currently engage most retina specialists. It was therefore easy for us to focus the 2018 ISOPT Clinical retinal discussions on delivery systems, drug efficacy and classic questions such as: have we reached the unbreakable glass ceiling of efficacy in wet age-related macular degeneration (AMD)? Can we aim our target to achieve an even higher effect? Can it be reached by new chemical/biological entities or would delivery system allow us to reach higher points of efficacy? The discussion also addressed the issue of dry AMD and the glorious parade of failures so far, and how do we measure success and failure via relevant endpoints.

Published
2019
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30. Rivaroxaban treatment of cancer-associated venous thromboembolism: Memorial Sloan Kettering Cancer Center institutional experience.

Author

Soff GA, Mones J, Wilkins C, Devlin S, Haegler-Laube E, Wills J, Sarasohn DM, Juluru K, Singer M, Miao Y, Batista J, and Mantha S

Abstract

Background: Low-molecular-weight heparin has been the preferred treatment of cancer-associated thrombosis (CAT); however, emerging data support the use of direct oral anticoagulants (DOACs)., Objectives: The Memorial Sloan Kettering Cancer Center Clinical Pathway has served as the institutional guideline for the use of rivaroxaban to treat CAT since 2014. Key elements are to recommend against use of a DOAC in patients with active gastrointestinal (GI) or genitourinary tract lesions, and a prespecified dose reduction in the elderly (75+ years old). We present our institutional experience for treatment of CAT., Methods: From January 2014 through September 2016, 1072 patients began rivaroxaban treatment for CAT; 91.9% had a solid tumor, 8.1% had hematologic malignancies, and 75% of patients with solid tumors had metastatic disease. All patients with CAT treated with rivaroxaban were included in this analysis, regardless of adherence to the Clinical Pathway., Results: The 6-month cumulative incidence of recurrent venous thromboembolism and major bleeding were 4.2% (95% confidence interval [CI], 2.7%-5.7%) and 2.2% (95% CI, 1.1%-3.2%), respectively. The incidence of clinically relevant non-major bleeding leading to discontinuation of rivaroxaban for at least 7 days was 5.5% (95% CI,  3.7%-7.1%), and 73.3% of major bleeds occurred in the GI tract. The 6-month cumulative mortality rate was 22.2% (95% CI, 19.4%-24.9%). The elderly had similar rates of recurrent thrombosis and bleeding as those aged under 75 years., Conclusion: Our institutional experience suggests that in appropriately selected patients, rivaroxaban may be used for treatment of CAT with promising safety and efficacy.

Published
2019
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32. Clear-cell melanocytic lesions with balloon-cell and sebocyte-like melanocytes: a unifying concept.

Author

Kazlouskaya V, Guo Y, Maia-Cohen S, and Mones J

Subjects
Adolescent, Adult, Aged, Female, Humans, Male, Melanoma pathology, Middle Aged, Nevus pathology, Precancerous Conditions pathology, Young Adult, Melanocytes pathology, Skin Neoplasms pathology
Abstract

Melanocytes may assume unique shapes and sizes but rarely have clear cytoplasm. We studied 28 melanocytic lesions that contained clear-cell melanocytes of the balloon-cell and sebocyte-like types. Clear-cell melanocytes were found more commonly in females (64%) than in males (36%), with predominance in females younger than 50 years (79%) and predominance in males older than 50 years (67%). They were distributed evenly throughout the body but were not found on acral sites. Clear-cell melanocytes were most prevalent in congenital nevi (18 or 72%) but were also found in 5 Clark nevi, 2 Meischer nevi, 1 Unna nevus, 1 atypical intra-epidermal proliferation, and 1 melanoma. The clear cells were distributed diffusely in 86% of the lesions and focally in 14%. The overall percentage of clear-cell melanocytes was 56%. The percentage of balloon cells was 57% and sebocyte-like melanocytes 32%. Clear cells with morphologic features of both balloon cells and sebocyte-like melanocytes, that is, intermediate cells, were present in all lesions with an overall percentage of 12%. The presence of melanocytes of both the balloon-cell and sebocyte-like types and the finding of clear-cell melanocytes with intermediate features in all lesions lends support to the theory that balloon-cell and sebocyte-like melanocytes may represent morphologic expressions of the same alteration in melanogenesis.

Published
2014
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36. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study.

Author

Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, and Goss TF

Subjects
Aged, Aged, 80 and over, Canada epidemiology, Case-Control Studies, Comorbidity, Cross-Cultural Comparison, Cross-Sectional Studies, Europe epidemiology, Female, Health Care Costs, Health Resources statistics & numerical data, Humans, Male, Middle Aged, Prospective Studies, Quality of Life, Sickness Impact Profile, Surveys and Questionnaires, Visual Acuity, Choroidal Neovascularization economics, Choroidal Neovascularization epidemiology, Cost of Illness, Macular Degeneration economics, Macular Degeneration epidemiology
Abstract

Background: There is limited previous research examining the healthcare costs of neovascular age-related macular degeneration (NV-AMD), which constrains our understanding of the economic impact of this condition. With aging populations, this leading cause of rapid vision loss in Western countries is expected to become a pressing health predicament, requiring decision makers to evaluate alternative treatment strategies for AMD., Objective: To document the economic burden of bilateral NV-AMD, the late stage of AMD, in elderly patients, from a societal perspective. STUDY DESIGN, SETTING AND PARTICIPANTS: A cross-sectional, observational study surveyed 401 patients with bilateral NV-AMD and 471 non-AMD subjects in Canada, France, Germany, Spain and the UK. Physicians' records and subjects' standardized telephone interviews were used to record medical resource utilization, assistance with daily living and social benefits. Annual bilateral NV-AMD-related socioeconomic costs were calculated in euro, year 2005 values., Main Outcome Measures: Societal costs including direct vision-related medical costs (e.g. treatment of AMD and vision-related equipment), direct non-vision-related medical costs (e.g. medications) and direct non-medical-related costs (e.g. home healthcare and social services) were the main outcome measures., Results: The demographic profile of NV-AMD patients was similar across countries; however, co-morbid condition profiles varied. NV-AMD patients reported substantial health-related problems and associated health resource utilization (HRU). In the previous 12 months, 12-22% of patients fell, and half of these patients required medical treatments. More than 20% (range 21-59%) of patients were prescribed vision-enhancing equipment. More than half of the patients (54-81%) were living with a spouse or family member and 19-41% reported receiving assistance for activities of daily living. The average annual societal cost per bilateral NV-AMD patient treated was estimated to be euro 7879 in Canada, euro 7349 in France, euro 12 445 in Germany, euro 5732 in Spain and euro 5300 in the UK, and direct vision-related medical costs accounted for 23-63% of the total cost. Half of the patients were diagnosed with bilateral NV-AMD for <1 year, with an average length of 5 months; there were no statistically significant differences in total annual costs per patient between these patients and those who were diagnosed with bilateral disease for > or =1 year. Estimated annual societal costs of bilateral NV-AMD patients in these countries ranged from euro 268 to euro 1311 million. Estimated annual societal costs of all NV-AMD patients in these countries ranged from euro 671 to euro 3278 million., Conclusions: Bilateral NV-AMD imposes significant functional impairment on patients, leading to increased HRU and a high societal cost burden. Differences in national healthcare systems and NV-AMD treatment patterns were reflected in the wide variation of NV-AMD costs across the five surveyed countries. Even though the prevalence rates and per-patient costs varied by country, the societal costs of NV-AMD patients were substantial in each country. Earlier intervention with effective therapies is expected to reduce disease burden and disability associated with NV-AMD and, thus, decrease the overall societal cost.

Published
2008
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37. Rapid growth of basal cell carcinoma in a multigestational pregnancy.

Author

Fisher GH, Bangash SJ, Mones J, and Geronemus RG

Subjects
Adult, Carcinoma, Basal Cell pathology, Carcinoma, Basal Cell surgery, Diagnosis, Differential, Female, Humans, Mohs Surgery, Neoplasm Invasiveness, Nose pathology, Nose surgery, Pregnancy, Pregnancy Complications, Neoplastic pathology, Pregnancy Complications, Neoplastic surgery, Pregnancy, Multiple, Skin Neoplasms pathology, Skin Neoplasms surgery, Surgical Flaps, Twins, Carcinoma, Basal Cell diagnosis, Pregnancy Complications, Neoplastic diagnosis, Skin Neoplasms diagnosis
Published
2006
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38. Seasonal variation of transient acantholytic dyskeratosis (Grover's disease).

Author

Scheinfeld N and Mones J

Subjects
Acantholysis etiology, Adult, Age Factors, Aged, Aged, 80 and over, Female, Humans, Incidence, Male, Middle Aged, Pruritus, Retrospective Studies, United States epidemiology, Acantholysis epidemiology, Acantholysis pathology, Ichthyosis complications, Seasons
Abstract

Background: Grover's disease (GD), or transient acantholytic dermatosis, is a pruritic, papulovesicular eruption characterized histopathologically by acantholysis with or without dyskeratosis. The origin of GD is unknown. Suggested causes include sweating, heat, immobilization occlusion, external beam and ultraviolet radiation, and xerosis. GD has also been found to occur in association with other diseases., Objective: Our aim was to assess whether GD exhibits seasonal variation and, if so, to determine whether any inferences can be drawn from its seasonal variation regarding its cause., Methods: We identified 385 patients who fulfilled both clinical and histopathologic criteria for GD among 423,106 patients diagnosed at the Ackerman Academy of Dermatopathology in New York City during the period from July 1, 1999 through June 30, 2004. By design, no hospitalized patients were studied., Results: A diagnosis of GD was given to 0.09% of biopsy specimens at the Ackerman Academy of Dermatopathology. GD was diagnosed approximately 4 times more commonly in winter than in summer, although the number of biopsies was constant. The average age of GD patients was 64 years with a male/female ratio of 1.95:1. The most common histopathologic type of GD was pemphigus vulgaris. GD was suspected clinically in 54% of patients., Limitations: This study did not assess hospitalized patients with GD or GD patients who lived outside the northeastern United States. Because the data assessed resided in a commercial dermatopathology laboratory, patients assessed in almost all cases had insurance coverage. Patients without insurance likely were not included in the study., Conclusions: The diagnosis of GD constitutes a higher proportion of biopsies in the winter than in the summer and therefore, by inference, occurs more frequently in the winter. In the winter, elderly men whose skin is naturally xerotic sweat less and are exposed to low ambient humidity. Rather than being caused by sweating and heat, GD arises against a backdrop of an intact but xerotic epidermis with decreased sweat production and is likely related to impaired epidermal integrity.

Published
2006
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39. Are all melanomas the same? Spitzoid melanoma is a distinct subtype of melanoma.

Author

Lee DA, Cohen JA, Twaddell WS, Palacios G, Gill M, Levit E, Halperin AJ, Mones J, Busam KJ, Silvers DN, and Celebi JT

Subjects
Adolescent, Adult, Aged, Child, Child, Preschool, DNA Mutational Analysis, Female, Humans, Male, Melanoma classification, Mitogen-Activated Protein Kinases metabolism, Signal Transduction, Skin Neoplasms classification, Genes, ras, Melanoma genetics, Melanoma physiopathology, Proto-Oncogene Proteins B-raf genetics, Skin Neoplasms genetics, Skin Neoplasms physiopathology
Abstract

Background: Although the majority of melanomas demonstrate high rates of mutations in B-RAF or N-RAS that result in constitutive activation of the mitogen-activated protein kinase-signaling pathway, emerging data suggest molecular differences among melanoma subtypes. In this study, the authors evaluated the contribution of B-RAF and N-RAS mutations to the pathogenesis of Spitzoid melanomas., Methods: In total, 33 Spitzoid melanomas were analyzed for clinical and pathologic characteristics as well as for hot-spot mutations in the B-RAF and N-RAS genes. In the majority of patients (28 of 33 melanomas), the tumors were confined to the skin with no evidence of metastasis (average follow-up, 32.5 mos). There were five metastasizing melanomas (5 of 33 tumors) with regional or systemic spread., Results: Of 33 Spitzoid melanomas, only 1 showed the V600E mutation in the B-RAF gene (1 of 33 tumors; 3%). It was noteworthy that none of the metastatic Spitzoid melanomas (0 of 5 tumors; 0%), of which 2 resulted in fatal outcomes, demonstrated mutations in B-RAF or N-RAS., Conclusions: In contrast to the majority of cutaneous melanomas, activating hot-spot mutations in B-RAF or N-RAS were not involved in the pathogenesis of Spitzoid melanoma. These data suggested that Spitzoid melanoma is a distinct form of melanoma with unknown genes and/or signaling pathways involved in its development., (Copyright 2006 American Cancer Society.)

Published
2006
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40. New perspectives on the treatment of age-related macular degeneration.

Author

Mones J

Subjects
Age Factors, Angiogenesis Inhibitors therapeutic use, Aptamers, Nucleotide therapeutic use, Choroidal Neovascularization drug therapy, Choroidal Neovascularization etiology, Choroidal Neovascularization therapy, Combined Modality Therapy, Genetic Therapy, Humans, Light Coagulation, Macular Degeneration complications, Macular Degeneration drug therapy, Photochemotherapy, Macular Degeneration therapy
Published
2005
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41. Mohs surgical extirpation of a basal cell carcinoma in a patient with familial multiple trichoepitheliomas.

Author

Fisher GH, Mones J, Gill M, Celebi JT, and Geronemus RG

Subjects
Adult, Carcinoma, Basal Cell pathology, Facial Neoplasms pathology, Female, Humans, Skin Neoplasms pathology, Surgical Flaps, Carcinoma, Basal Cell genetics, Carcinoma, Basal Cell surgery, Facial Neoplasms genetics, Facial Neoplasms surgery, Mohs Surgery, Skin Neoplasms genetics, Skin Neoplasms surgery
Abstract

Background: The success of Mohs surgery relies on the ability to histologically differentiate tumor from the normal background tissue of the patient. In most cases of basal cell carcinoma and nonmelanoma skin cancer, this is a relatively straightforward process. However, in distinction, when only subtle histopathologic features differentiate the background tissue from the tumor of interest, the determination of a tumor-free margin becomes more challenging., Objective: Our objective is to highlight the histopathologic features that we used to differentiate our patient's near-confluent background of trichoepitheliomas from the basal cell carcinoma that we were extirpating., Methods: Case report., Results: A 41-year-old white female with a history of familial multiple facial trichoepitheliomas presented for removal of a basal cell carcinoma on her right lower cutaneous lip. Mohs surgery was used to remove the tumor. The characteristic features of basal cell carcinoma and trichoepithelioma were used to differentiate the basal cell carcinoma that we were removing from the surrounding trichoepitheliomatous neoplasia., Conclusion: Mohs surgical extirpation of a basal cell carcinoma in a patient with multiple familial trichoepitheliomas requires a clear understanding of the histopathologic features that differentiate a trichoepithelioma from a basal cell carcinoma.

Published
2005
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42. Granular parakeratosis: pathologic and clinical correlation of 18 cases of granular parakeratosis.

Author

Scheinfeld NS and Mones J

Subjects
Adult, Aged, Axilla pathology, Female, Humans, Male, Middle Aged, Parakeratosis diagnosis, Retrospective Studies, Parakeratosis pathology
Abstract

Background: Granular parakeratosis (originally termed axillary granular parakeratosis) is an idiopathic, benign, nondisabling cutaneous disease that manifests with intertriginous erythematous, brown or red, scaly or keratotic papules and plaques. It presents in all age groups and has no established clinical associations., Objectives: We wanted to assess the following: (1) the incidence of granular parakeratosis in biopsy specimens; (2) the differential diagnosis submitted with specimens requisition of granular parakeratosis; and (3) variations in its histopathology., Methods: Between July 1, 1999 and December 31, 2003, 363,343 specimens were submitted to The Ackerman Institute of Dermatopathology in New York. A computer search was done of these specimen records and cases diagnosed with granular parakeratosis were reviewed. A thickened stratum corneum with retention of keratohyalin granules was considered diagnostic of granular parakeratosis., Results: Eighteen of 363,343 specimens (0.005%) were diagnosed with granular parakeratosis. The diagnosis was confirmed by re-review of specimens. All lesions were located in the axillae. All patients were adults; most were women. In only one instance was the correct clinical diagnosis of granular parakeratosis submitted with a biopsy requisition of it. Granular parakeratosis is rare, if its incidence among biopsy specimens is representative of its true prevalence. The failure to include granular parakeratosis on biopsy requisition forms of granular parakeratosis specimens indicates that dermatologists are not familiar with it. Variations of the histopathology of the 18 cases occurred but did not correlate with the clinical impressions included on biopsy requisition forms.

Published
2005
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43. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trials: Treatment Of Age-Related Macular Degeneration With Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report no. 4.

Author

Azab M, Benchaboune M, Blinder KJ, Bressler NM, Bressler SB, Gragoudas ES, Fish GE, Hao Y, Haynes L, Lim JI, Menchini U, Miller JW, Mones J, Potter MJ, Reaves A, Rosenfeld PJ, Strong A, Su XY, Slakter JS, Schmidt-Erfurth U, and Sorenson JA

Subjects
Aged, Choroidal Neovascularization etiology, Female, Humans, Macular Degeneration complications, Male, Photosensitizing Agents adverse effects, Porphyrins adverse effects, Randomized Controlled Trials as Topic, Safety, Treatment Outcome, Verteporfin, Visual Acuity drug effects, Choroidal Neovascularization drug therapy, Macular Degeneration drug therapy, Photochemotherapy, Photosensitizing Agents therapeutic use, Porphyrins therapeutic use
Abstract

Purpose: We sought to evaluate the detailed safety profile of photodynamic therapy with verteporfin in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (ARMD) from the combined analysis of three multicenter, double-masked, placebo-controlled, randomized 24-month clinical trials of similar design (TAP Investigation Studies A and B and the VIP ARMD Trial), and to clarify the adverse reaction information in the current verteporfin product prescription information approved in the United States., Methods: Nine hundred forty-eight patients were randomly assigned to verteporfin or placebo. Treatment was administered as described in previous reports. All general entry criteria were similar, so systemic safety results were combined for this analysis. Entry criteria for CNV lesion composition and visual acuity in the two TAP Investigation trials was different from those used in the VIP ARMD trial, so ocular safety results for the treated eye were not combined., Results: The percentage of patients who experienced at least one ocular or nonocular adverse event, regardless of relationship to therapy, was similar between the verteporfin and placebo groups (92.3 and 89.1%, respectively, P = 0.114). The overall incidence of study eye adverse events was not significantly different between verteporfin and placebo. The only clinically relevant ocular adverse events reported with higher incidence after verteporfin compared with placebo were visual disturbances (22.1 versus 15.5% in TAP [P = 0.054] and 41.7 and 22.8% in VIP [P < 0.001]). Acute severe visual acuity decrease (defined as a visual acuity letter score decrease of at least 20, equivalent to at least four-line decrease, within 7 days of therapy) occurred in 3 patients treated with verteporfin in the TAP Investigation (0.7%) and 11 in the VIP ARMD trial (4.9%). Systemic adverse events with increased incidence after verteporfin compared with placebo, most of which were transient and mild or moderate, were injection site reactions (13.1 versus 5.6%; P < 0.001), photosensitivity reactions (2.4 versus 0.3%; P = 0.016), and infusion-related back pain (2.4 versus 0%; P = 0.004). No clinically relevant difference was observed between the verteporfin and placebo groups in any other adverse event., Conclusion: In 948 ARMD patients, verteporfin therapy had an overall safety profile similar to that for placebo, with a few exceptions. Visual disturbances, including acute severe visual acuity decrease, did not affect the net vision outcome benefits associated with treatment that has been reported previously. This detailed safety profile of verteporfin therapy clarifies the adverse reaction information in the current verteporfin product prescription information.

Published
2004
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44. Fatal Aspergillus myocarditis following short-term corticosteroid therapy for chronic obstructive pulmonary disease.

Author

Carrascosa Porras M, Herreras Martínez R, Corral Mones J, Ares Ares M, Zabaleta Murguiondo M, and Rüchel R

Subjects
Anti-Inflammatory Agents administration & dosage, Fatal Outcome, Humans, Male, Methylprednisolone administration & dosage, Methylprednisolone adverse effects, Methylprednisolone therapeutic use, Middle Aged, Mycoses complications, Mycoses microbiology, Anti-Inflammatory Agents adverse effects, Anti-Inflammatory Agents therapeutic use, Aspergillus, Myocarditis complications, Myocarditis microbiology, Pulmonary Disease, Chronic Obstructive complications, Pulmonary Disease, Chronic Obstructive drug therapy
Abstract

A 58-y-old man with chronic obstructive pulmonary disease (COPD) was admitted for treatment of an acute exacerbation of his illness. The patient's condition initially improved after therapy with oxygen, bronchodilators, antibiotic and methylprednisolone (40 mg every 8 h) was started. Soon afterwards, however, the patient's clinical status deteriorated and he died on the fifth hospital day. Post-mortem examination revealed unsuspected, isolated fungal myocarditis. The fungus was later identified as Aspergillus by indirect immunofluorescence. To our knowledge, this is the first case of fatal Aspergillus myocarditis related to short-term (< 1 week) steroid therapy in a COPD patient. We believe that this case provides further evidence to support the possibility of life-threatening infections in COPD patients who receive even a short course of corticosteroid treatment.

Published
2002
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45. New insights into old common problems. II.

Author

Ackerman AB, Mones J, and Guo Y

Subjects
Diagnosis, Differential, Humans, Nevus, Pigmented classification, Keratosis, Seborrheic pathology, Lentigo pathology, Melanoma pathology, Nevus, Pigmented pathology, Skin Neoplasms pathology
Published
2000

47. Diagnosis of Pneumocystis carinii pneumonia. Roentgenographic-pathologic correlates based on fiberoptic bronchoscopy specimens from patients with the acquired immunodeficiency syndrome.

Author

Mones JM, Saldana MJ, and Oldham SA

Subjects
Acquired Immunodeficiency Syndrome diagnostic imaging, Adult, Biopsy methods, Bronchoscopy, Fiber Optic Technology instrumentation, Humans, Male, Middle Aged, Pneumonia, Pneumocystis diagnostic imaging, Radiography, Therapeutic Irrigation, Acquired Immunodeficiency Syndrome pathology, Lung pathology, Pneumonia, Pneumocystis pathology
Abstract

We analyzed the diagnosis of Pneumocystis carinii pneumonia by fiberoptic bronchoscopy in a large series of patients with the acquired immunodeficiency syndrome (AIDS). Transbronchial biopsy fragments, as opposed to endobronchial specimens, were found to have high diagnostic value. Their optimal number for diagnosis was determined by a simple statistical principle. It varied from a minimum of two in cases of severe pneumonia to a maximum of four when roentgenographic manifestations were altogether absent. The diagnostic yield of the transbronchial biopsy alone was 97 percent and that of "touch" preparations of the biopsies 88 percent; when both techniques were combined, the accuracy rose to 98 percent. By comparison, bronchial "washings" and "brushings" had a much lower yield, 59 percent and 57 percent, respectively. Because their diagnostic contribution was negligible, we conclude that the latter two procedures represent an unnecessary expense and waste of technical and professional effort.

Published
1986
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48. Intestinal metaplasia of the gallbladder: a morphologic and immunocytochemical study.

Author

Albores-Saavedra J, Nadji M, Henson DE, Ziegels-Weissman J, and Mones JM

Subjects
Adult, Aged, Female, Histocytochemistry, Hormones metabolism, Humans, Immunochemistry, Male, Metaplasia, Middle Aged, Peptides metabolism, Somatostatin metabolism, Gallbladder pathology, Intestines pathology
Abstract

The morphologic spectrum of intestinal metaplasia was studied in 49 gallbladders that had been excised because of cholelithiasis. Based on the absence or presence of endocrine cells, the cases of intestinal metaplasia were arbitrarily divided into two groups. The gallbladders from the first group (26 cases) contained isolated or small clusters of mature goblet cells, while those from the second group (23 cases), in addition to the goblet cells, contained argyrophil and argentaffin cells and, less frequently, Paneth cells and gland-like structures similar to colonic crypts. Pseudopyloric glands and superficial gastric-type epithelium were present in both groups. Argyrophil cells outnumbered argentaffin cells by a ratio of 4 to 1. By immunocytochemical methods serotonin-containing cells were found to be the most common endocrine cells. Other endocrine cells showed immunoreactivity for somatostatin, cholecystokinin, gastrin, and pancreatic polypeptide. The presence of gut endocrine cells and Paneth cells in the pseudopyloric glands suggests that these glands are also an integral component of intestinal metaplasia of the gallbladder. The findings support the hypothesis that cholelithiasis induces the appearance of a stem endodermal cell that, in turn, may differentiate into cells with mature intestinal or gastric phenotypes.

Published
1986
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49. Cavitation and other atypical manifestations of Pneumocystis carinii pneumonia.

Author

Saldana MJ and Mones JM

Subjects
Acquired Immunodeficiency Syndrome complications, Acquired Immunodeficiency Syndrome pathology, Animals, Humans, Lung physiopathology, Pneumonia, Pneumocystis physiopathology, Lung pathology, Pneumonia, Pneumocystis pathology
Abstract

In the 1980s, under the impact of the acquired immune deficiency syndrome, Pneumocystis carinii Pneumonia (PCP) has become the prime infectious manifestation of this condition. In addition to the well-recognized "classic" features of this disease, several unusual manifestations are being recognized with increasing frequency. We presently review and illustrate the following "atypical" manifestations of PCP: (1) interstitial lung responses that include diffuse alveolar damage, bronchiolitis obliterans, interstitial fibrosis, and lymphoplasmacytic infiltrates; (2) striking localized processes frequently exhibiting granulomatous features; (3) extensive necrosis and cavitation; and (4) extrapulmonary dissemination of the disease. Close clinico-pathologic correlation and attention to roentgenographic detail are invaluable aids in arriving at the correct diagnosis.

Published
1989

50. The pathology of treated Pneumocystis carinii pneumonia.

Author

Saldana MJ, Mones JM, and Martinez GR

Subjects
Adult, Anti-Infective Agents pharmacology, Anti-Infective Agents therapeutic use, Female, Humans, Lung drug effects, Lung pathology, Male, Middle Aged, Pneumonia, Pneumocystis therapy, Trimethoprim, Sulfamethoxazole Drug Combination pharmacology, Trimethoprim, Sulfamethoxazole Drug Combination therapeutic use, Pneumonia, Pneumocystis pathology
Abstract

Post-mortem examinations were conducted in 28 patients with the acquired immune deficiency syndrome (AIDS) and biopsy-proven Pneumocystis carinii pneumonia (PCP) who had been treated with trimethoprim-sulfamethoxazole (Bactrim, intravenous infusion [Roche]) and/or pentamidine isethionate. According to the evolution of the pulmonary process, the cases were classified into three groups. Group I ("fulminant" PCP) was composed of eight patients who died during the first week of the disease. Although treatment had eradicated most of the organisms, one third of the alveolar space volume, on the average, was filled by foamy exudates characteristic of PCP. This accounted for the respiratory insufficiency and death of these patients. Group II ("nonresolving" PCP) was comprised of nine patients who died within eight days and 2 months of diagnosis. PCP was less severe than in group I, but fatal respiratory insufficiency was the result of fibroblastic organization of the intraalveolar exudates (fibrosing alveolitis). In seven of the nine patients (78%), the latter resulted from oxygen toxicity; in the remaining two patients (22%) PCP, per se, was the original stimulus for the fibrosis. Patients in group II also had a high incidence of thromboembolic pulmonary lesions. Group III ("cured" PCP) was composed of 11 patients who responded dramatically well to therapy but died months or years later of other manifestations of AIDS. In group III patients, the roentgenographic picture at diagnosis was consistently less severe than in groups I and II.

Published
1989

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