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PURPOSE To compare the efficacy and safety of brolucizumab with aflibercept in patients with diabetic macular edema (DME). DESIGN Double-masked, 100-week, multicenter, active-controlled, randomized trials. METHODS Subjects were randomized 1:1:1 to brolucizumab 3 mg/6 mg or aflibercept 2 mg in KESTREL (n = 566) or 1:1 to brolucizumab 6 mg or aflibercept 2 mg in KITE (n = 360). Brolucizumab groups received 5 loading doses every 6 weeks (q6w) followed by 12-week (q12w) dosing, with optional adjustment to every 8 weeks (q8w) if disease activity was identified at predefined assessment visits; aflibercept groups received 5 doses every 4 weeks (q4w) followed by fixed q8w dosing. The primary endpoint was best-corrected visual acuity (BCVA) change from baseline at Week 52; secondary endpoints included the proportion of subjects maintained on q12w dosing, change in Diabetic Retinopathy Severity Scale score, and anatomical and safety outcomes. RESULTS At Week 52, brolucizumab 6 mg was noninferior (NI margin 4 letters) to aflibercept in mean change in BCVA from baseline (KESTREL: +9.2 letters vs +10.5 letters; KITE: +10.6 letters vs +9.4 letters; P < .001), more subjects achieved central subfield thickness (CSFT)

Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD).TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300).Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [-1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [-1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]).Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD.F Hoffmann-La Roche.

Objective To evaluate the effectiveness, treatment patterns and long-term safety of ranibizumab 0.5 mg in treatment-naïve patients with central retinal vein occlusion (CRVO) in a real-world setting. Methods LUMINOUS, a 5-year, global, prospective, multicentre, multi-indication, observational, open-label study, recruited treatment naïve or prior treated patients who were treated as per the local ranibizumab label. Here, we report the mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), treatment exposure over year (Y) 1 and 5-year safety in treatment-naïve CRVO patients. Results At baseline, the mean age of treatment-naïve CRVO patients (n = 327) was 68.9 years, with a mean (Standard deviation [SD]) VA of 40.6 (23.9) letters. At Y1, patients (n = 144) had a mean (SD) VA gain from baseline of 10.8 (19.66) letters, with a mean (SD) of 5.4 (2.65) ranibizumab injections. Patients demonstrated mean (SD) VA gains of 2.7 (19.35), 11.6 (20.56), 13.9 (18.08), 11.1 (18.46) and 8.2 (24.86) letters with 1, 2–3, 4–5, 6–8 and >8 ranibizumab injections, respectively. Mean (SD) VA gains at Y1 in patients receiving loading (67.4%) and no loading dose (32.6%) was 11.9 (20.42) and 8.4 (17.99) letters, respectively. Over five years, the incidence of ocular/non-ocular adverse events (AEs) and serious AEs was 11.3%/8.6% and 1.2%/6.7%, respectively. Conclusions These results demonstrate the effectiveness of ranibizumab in treatment-naïve CRVO patients at Y1 with clinically meaningful VA gains and no new safety findings over five years. These findings may help inform routine practice and enable better clinical management to achieve optimal visual outcomes.

To evaluate the effectiveness, treatment patterns and long-term safety of ranibizumab 0.5 mg in treatment-naïve patients with central retinal vein occlusion (CRVO) in a real-world setting.LUMINOUS, a 5-year, global, prospective, multicentre, multi-indication, observational, open-label study, recruited treatment naïve or prior treated patients who were treated as per the local ranibizumab label. Here, we report the mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), treatment exposure over year (Y) 1 and 5-year safety in treatment-naïve CRVO patients.At baseline, the mean age of treatment-naïve CRVO patients (n = 327) was 68.9 years, with a mean (Standard deviation [SD]) VA of 40.6 (23.9) letters. At Y1, patients (n = 144) had a mean (SD) VA gain from baseline of 10.8 (19.66) letters, with a mean (SD) of 5.4 (2.65) ranibizumab injections. Patients demonstrated mean (SD) VA gains of 2.7 (19.35), 11.6 (20.56), 13.9 (18.08), 11.1 (18.46) and 8.2 (24.86) letters with 1, 2-3, 4-5, 6-8 and8 ranibizumab injections, respectively. Mean (SD) VA gains at Y1 in patients receiving loading (67.4%) and no loading dose (32.6%) was 11.9 (20.42) and 8.4 (17.99) letters, respectively. Over five years, the incidence of ocular/non-ocular adverse events (AEs) and serious AEs was 11.3%/8.6% and 1.2%/6.7%, respectively.These results demonstrate the effectiveness of ranibizumab in treatment-naïve CRVO patients at Y1 with clinically meaningful VA gains and no new safety findings over five years. These findings may help inform routine practice and enable better clinical management to achieve optimal visual outcomes.

Internal limiting membrane (ILM) grafting provides a useful option for repair of large and refractory macular holes that fail to close following prior ILM removal. However, current ILM graft techniques are associated with several challenges that may result in failure, most notably the difficulty in maintaining the graft in situ. In this video, the authors describe their modified technique for ILM grafting using a double layer of viscoelastic for stabilization in situ during the procedure. Four of five eyes managed with this technique demonstrated type 1 closure, and all eyes demonstrated improvement in visual acuity.

Purpose: To investigate the anatomical success rate associated with rhegmatogenous retinal detachment (RRD) repair without postoperative head positioning. Methods: Data on 182 individuals undergoing pars plana vitrectomy (PPV) with or without phacoemulsification or scleral buckle for primary RRD with intraocular tamponade were retrospectively reviewed. The primary outcome was the initial anatomical success rate. Secondary outcome measures were the change in best-corrected visual acuity and the final reattachment rate. Results: A total of 122 eyes from 122 patients who underwent RRD repair without postoperative positioning were included in this study. PPV alone was performed in 39% of cases, whereas the remaining patients had PPV combined with phacoemulsification (35%), with scleral buckle (19%), or both (7%). Inferior breaks between the 4 o’clock and 8 o’clock positions were present in 47% of cases. Primary and final anatomical success was achieved in 86% and 98% of cases, respectively. The most common cause for redetachment was proliferative vitreoretinopathy. Age and combined inferior retinal and superior breaks were predictive of recurrence in the logistic regression model. The mean baseline best-corrected visual acuity improved from 1.2 (Snellen equivalent, 20/320) to 0.76 (Snellen, 20/125) logarithm of the minimum angle of resolution after retinal reattachment ( P < .001). Conclusions: PPV combined with or without phacoemulsification or scleral buckle for primary RRD in pseudophakic eyes or those rendered pseudophakic is associated with good anatomical outcomes without restricted postoperative head positioning. Retinal detachment in eyes with combined retinal inferior and superior breaks may have a lower success rate, and whether this is due to lack of postoperative positioning needs further evaluation in prospective, controlled studies.

Background: The Heidelberg retina tomograph, a scanning laser ophthalmoscope that uses confocal optics to provide high resolution of images, is able to scan the retina in three dimensions to obtain quantitative topographic measurements. The authors evaluated its usefulness for measuring macular lesions by determining the reproducibility of its topographic measurements at the macula. Methods: : For each of ten healthy patients, the authors took five images with the patient's right eye undilated and five with the eye cyclopleged and dilated. As a measure of reproducibility, the standard deviation of height measurements for the same location at the macula was calculated for each patient and then the pooled standard deviation for all patients was calculated. The authors performed similar calculations for the mean depth within a contour line. Results: The pooled standard deviation for height measurements was 47.4 μm in undilated eyes and 36.0 μm in cyclopleged, dilated eyes. The authors obtained an extremely low standard deviation of 2.2 μm when the software calculated relative differences between measurements, such as the mean depth within a contour line. When the average of three height measurement values on 1 day was compared with the average of the three values on another day, the 95% confidence interval was ±58.7 gum for mean height values and ±3.7 ,um for mean depth values within a contour line. Conclusions: The authors obtained good reproducibility for height measurements with the Heidelberg retina tomograph and excellent reproducibility when the instrument calculated relative differences in height measurements. The authors recommend that patients, especially young patients, be dilated and cyclopleged to obtain lower variability of measurements. This scanning laser ophthalmoscope could potentially be used to quantify small changes in retinal lesions.

To assess the surgical success rates of modern macular hole repair with elimination of face down positioning.A review of data for 72 eyes (from 102 consecutive cases) with idiopathic macular holes treated surgically between 1998 and 2004 was performed. Exclusion criteria consisted of macular hole for1 year or of unknown duration and macular holes from secondary causes. All patients were evaluated and surgically managed by one surgeon (R.T.).Average preoperative best spectacle corrected visual acuity (BSCVA) was 20/170 (6/51). Six patients had a grade II hole, 60 patients had a grade III hole, and 6 patients, had a grade IV hole. Anatomical success was achieved in 92% of cases with 1 operation, and the average postoperative BSCVA was 20/46 (6/14). Six patients required additional surgical management to achieve anatomical success with an average postoperative BSCVA of 20/55 (6/16.5). The postoperative BSCVA improved an average of 5.7 lines from baseline.Favorable anatomical and BSCVA outcomes were achieved with the elimination of face down positioning in the postoperative period. Additional benefits are an increase in patient acceptance and compliance and the number of patients eligible for the procedure.

R etinal neovascularization with angioma formation is an uncommon late complication of scleral buckling surgery that has successfully reattached the retina. 1 Delayed development of an angiomatous mass at the site of choroidal perforation for drainage of subretinal fluid was reported by Gottlieb and colleagues.1 We present a case involving the late development of an internal angiomatous mass over a scleral buckle, which we believe was secondary to a suture that eroded into the intraocular space.