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David Boyer,1 K Bailey Freund,2 Carl Regillo,3 Marc H Levy,4 Sumit Garg5 1Retina-Vitreous Associates Medical Group, Beverly Hills, CA, 2Vitreous-Retina-Macula Consultants of New York, New York, NY; 3Wills Eye Institute, Philadelphia, PA, 4Sarasota Retina Institute, Sarasota, FL, 5The Gavin Herbert Eye Institute (University of California, Irvine) Irvine, CA, USA Background: The purpose of this study was to evaluate the long-term results of an implantable miniature telescope (IMT) in patients with bilateral, end-stage, age-related macular degeneration (AMD).Methods: A prospective, open-label, multicenter clinical trial with fellow eye controls enrolled 217 patients (mean age 76 years) with AMD and moderate-to-profound bilateral central visual acuity loss (20/80–20/800) resulting from untreatable geographic atrophy, disciform scars, or both. A subgroup analysis was performed with stratification for age (patient age 65 to 30 days after surgery (7/70; 10%) and persistent corneal edema (3/70; 4.3%); and in group 2 were a decrease in BCDVA in the implanted eye or IMT removal (10/127 each; 7.9%), corneal edema >30 days after surgery (9/127; 7.1%), and persistent corneal edema (6/127; 4.7%). Significant adverse events included four corneal transplants, comprising two (2.9%) in group 1 and two (1.6%) in group 2. At 60 months, one patient in group 1 (3.2%) and three patients in group 2 (9.4%) had lost ≥2 lines of vision. The IMT was removed in one (1.4%) and ten (7.9%) patients in group 1 and group 2, respectively. Mean ECD loss was 20% at 3 months. Chronic loss was 3% per year. ECD loss was less in group 1 than in group 2 (35% versus 40%, respectively) at 60 months.Conclusion: Long-term results show substantial retention of improvement in BDCVA. Chronic ECD loss was consistent with that reported for conventional intraocular lenses. The IMT performed as well in group 1 (the younger group) as it did in group 2 through month 60. Younger patients retained more vision than their older counterparts and had fewer adverse events. Although not a specified outcome for this study, patients younger than 65 years also fared better than those in group 2 and retained more vision with fewer adverse events through month 60. Keywords: end-stage age-related macular degeneration, implantable miniature telescope, low vision

Carl D Regillo,1 Lisa M Nijm,2 Diana L Shechtman,3 Peter K Kaiser,4 Paul M Karpecki,5 Edwin H Ryan,6 Michael S Ip,7 Elizabeth Yeu,8 Terry Kim,9 Mohammad R Rafieetary,10 Eric D Donnenfeld11 1Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA; 2Warrenville Eye Care and LASIK Center, Warrenville, IL, USA; 3Eye Centers of South Florida, North Miami Beach, FL, USA; 4Cole Eye Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA; 5Kentucky College of Optometry, University of Pikeville, Pikeville, KY, USA; 6Retina Consultants of Minnesota, Edina, MN, USA; 7Doheny Eye Center UCLA, Pasadena, CA, USA; 8Virginia Eye Consultants, Norfolk, VA, USA; 9Duke University, Durham, NC, USA; 10Charles Retina Institute, Germantown, TN, USA; 11Ophthalmic Consultants of Long Island, Garden City, NY, USACorrespondence: Carl D Regillo, Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, 840 Walnut St # 1020, Philadelphia, PA, 19107, USA, Tel +1 (215) 928-3300, Email cregillo@midatlanticretina.comAbstract: Newly approved treatments for patients with geographic atrophy are changing the treatment paradigm, highlighting the need for eye care providers (ECPs) to have a set of recommendations on how to best manage GA patients. Here, we outline how to identify various stages of age-related macular degeneration including geographic atrophy (GA) by examining optimal management scenarios implicating various ECPs and reviewing treatment considerations for patients with GA. Early identification of GA will lead to optimal patient outcomes, while a standardized management scenario will reduce clinical burden among ECPs treating patients with GA.Keywords: age-related macular degeneration, patient care, retina, treatment

Purpose: Disparities in clinical trials are a major problem because of significant underrepresentation of certain gender, racial, and ethnic groups. Several factors including stringent eligibility criteria and recruitment strategies hinder our understanding of retinal disease. Thus, we aimed to study the various reasons of screen failures and specific patient and study characteristics among screen failures., Design: This is a cross-sectional retrospective study., Methods: Screening data of 87 trials from 6 centers were analyzed. Study characteristics (disease studied, phase of trial, and route of drug administration) and patient demographics (age, gender, race, ethnicity, and employment status) were compared among different causes of screen failures. Screen failures were broadly classified into 6 categories: exclusion because of vision-based criteria, exclusion because of imaging findings, exclusion because of other factors, patient-related criteria, physician-related criteria, and miscellaneous. Descriptive statistics, Pearson chi-square test, and analysis of variance were used for statistical analysis., Main Outcome Measures: Prevalence of various reasons for screen failures in multiple trials and its trend among different study and patient characteristics., Results: Among 87 trials and 962 patients, 465 (48.2%) patients were successfully randomized and 497 (51.8%) patients were classified as screen failures. The trials were conducted for various retinal diseases. Mean age was 76.50 ± 10.45 years and 59.4% were females. Predominantly White patients (93.4%) and unemployed/retired patients (66.6%) were screened. Of the 497 screen failures, most were because of patients not meeting inclusion criteria of imaging findings (n = 221 [44.5%]) followed by inclusion of vision-based criteria (n = 73 [14.7%]), exclusion because of other factors (n = 75 [15.1%]), patient-related (n = 34 [6.8%]), physician-related (n = 28 [5.6%]), and miscellaneous reasons (n = 39 [7.8%]). Reason for screen failure was not available for 27 (5.4%) patients. A higher proportion of patients screened for surgical trials (15%) declined to participate in the study compared with noninvasive trials involving topical drugs and photobiomodulation (0%) (P = 0.02)., Conclusions: Patients not meeting the imaging and vision-cased criteria were the most common reasons for screen failures. White patients and unemployed patients predominantly participated in clinical trials. Patients are more inclined to continue participation in noninvasive clinical trials compared with surgical trials. Better recruitment strategies and careful consideration of study criteria can aid in decreasing the rate of screen failures., Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article., (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Background: Retrospective cohort study of 561 adult patients undergoing secondary intraocular lens (IOL) implantation by vitreoretinal surgeons at a single institution from April 2015 to December 2020., Methods: Patient historical factors, intraoperative/postoperative complications, and outcomes of IOL type (anterior chamber IOL versus scleral sutured IOL versus scleral fixated IOL versus. sulcus) were assessed. Primary outcomes were rates of postoperative retinal tears and rhegmatogenous retinal detachment. Secondary outcomes were rates of intraoperative endolaser, intraoperative retinal tear, and further IOL surgery., Results: The incidence of intraoperative retinal tears was 7.3% and not significantly different between techniques. Rates of intraoperative endolaser use were 17.5% among all techniques and not significantly different between techniques. Rates of postoperative retinal tear were low (0%-2.7%). Rates of postoperative rhegmatogenous retinal detachment were not significantly different between techniques (anterior chamber IOL 9/198 [4.5%], SFIOL 1/54 [1.9%], scleral sutured IOL 14/274 [5.1%], sulcus 2/35 [5.7%], total 26/561 [4.6%], P = 0.79). Rates of repeat IOL surgery trended higher in sulcus lenses (anterior chamber IOL 5/198 [2.5%], SFIOL 4/54 [7.4%], scleral sutured IOL 16/274 [5.8%], sulcus 5/35 [14.3%], total 30/561 [5.3%], P = 0.12)., Conclusion: Intraoperative endolaser use and intraoperative retinal tear are not uncommon in secondary IOL surgery and underscore the importance of careful vitreoretinal management among these patients.

Purpose: To assess the anatomic and functional outcomes in eyes with neovascular age-related macular degeneration (nAMD) previously treated with anti-VEGF therapy in response to intravitreal faricimab., Design: Retrospective, interventional, consecutive case series., Subjects: Patients with previously treated nAMD who received ≥ 4 consecutive injections of faricimab were included. The study period was from March through November 2022., Methods: Clinical and imaging data were extracted from the electronic medical record. Central foveal thickness (CFT), maximum fibrovascular pigment epithelial detachment (fvPED) height, and Snellen visual acuity (VA) were obtained. Generalized estimating equations were used to analyze the change in CFT, maximum fvPED height, and logarithm of the minimum angle of resolution VA., Main Outcome Measures: Change in CFT, maximum fvPED height, and Snellen VA before faricimab and after ≥ 4 faricimab intravitreal injections., Results: During the study period, 218 eyes of 191 patients met inclusion criteria. Mean age was 79.9 (range, 70.6-89.2) years. The mean number of intravitreal anti-VEGF injections received before faricimab was 34.2 (range, 6.4-62). The following results were found after ≥ 4 faricimab injections. Mean logarithm of the minimum angle of resolution VA before switching to faricimab was 0.58 (Snellen VA ∼20/76; range, 20/22-20/264) and was 0.55 (Snellen VA ∼20/71; range, 20/21-20/235; P = 0.20) after switching. Mean maximum fvPED height was 195.0 (range, 50.2-339.8) μm before switching to faricimab and improved to 165.0 (range, 33.6-296.4; P < 0.001) μm after switching. Mean CFT was 354.8 (range, 184.7-524.9) μm before switching to faricimab and improved to 306.6 (range, 144.4-468.8; P < 0.001) after switching. The proportion of eyes with intraretinal fluid was 36.7% (80/218 eyes) before switching, and decreased to 24.8% (54/218 eyes, P < 0.001) after switching. The proportion of eyes with subretinal fluid was 53.2% (116/218 eyes) before switching and decreased to 26.6% (58/218 eyes, P < 0.001) after switching., Conclusions: Intravitreal faricimab may improve anatomic outcomes in patients with previously treated nAMD, while maintaining VA in the short-term., Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2023 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To report the 100-week outcomes from the KESTREL and KITE trials., Design: Two phase 3, double-masked, active-controlled, randomized trials., Methods: Patients with diabetic macular edema (DME) were randomized 1:1:1 to brolucizumab 3 mg/6 mg (BRO3/BRO6) or aflibercept 2 mg (AFL) in KESTREL (N = 566) or 1:1 to BRO6 or AFL in KITE (N = 360). BRO3/BRO6 arms received 5 loading doses every 6 weeks (q6w) followed by q12w dosing, with an option to adjust to q8w at predefined disease activity assessment visits. In KITE, at week 72, based on the disease stability assessment, treatment intervals could be extended by 4 weeks in the BRO6 arm. AFL arms received 5 monthly loading doses followed by fixed q8w dosing., Results: At week 100, change from baseline in BCVA (letters) was +8.8 for BRO6 and +10.6 for AFL in KESTREL; and +10.9 for BRO6 and +8.4 for AFL in KITE. In both studies, fewer BRO6 subjects had intraretinal fluid and/or subretinal fluid than AFL subjects. Results were achieved with 32.9% (KESTREL) and 47.5% (KITE) of BRO6 subjects maintained on q12w and q12w/q16w dosing, respectively. Intraocular inflammation rates for BRO6 vs AFL were 4.2% vs 1.1% (KESTREL) and 2.2% vs 1.7% (KITE), of which retinal vasculitis rates were 0.5% vs 0% in KESTREL, with no cases in KITE. Retinal vascular occlusion rates were 1.6% vs 0.5% (KESTREL) and 0.6% in both treatment arms in KITE., Conclusions: Results show the long-term efficacy and durability of brolucizumab in improving visual and anatomical outcomes in DME; the overall safety profile of brolucizumab remained unchanged through year 2., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate for the presence, severity, and type of exudation at each study visit for a subgroup of patients with neovascular age-related macular degeneration from the Archway and Portal trials., Design: Retrospective analysis of prospectively obtained data., Methods: Spectral-domain optical coherence tomography scans from each study visit of 44 patients from the Port Delivery System (PDS) arm and 32 patients from the monthly injection arm of Archway were evaluated, and composites of horizontal scans through the fovea were created. Each composite was graded for the presence, type, and severity of exudation and impact on best-corrected visual acuity., Results: After PDS implantation, 20 of 44 eyes (45%) never showed any exudation in the fovea, 2 (5%) never showed exudation in the fovea but had several missed visits, whereas 15 (34%), 3 (7%), and 4 (9%) showed mild, moderate, or severe exudation at 1 or more study visits, respectively. When exudation was present, it was most commonly subretinal fluid (50%). Of 32 patients randomized to monthly injections, 15 (47%) had no exudation in the fovea during monthly injections or after PDS implantation. Fluctuation of exudation in the fovea over time was seen in some patients after PDS implantation or during monthly injections with little or no identifiable impact on best-corrected visual acuity. In the 7 eyes with moderate or severe exudation in the fovea after PDS implantation, final vision was good in 5 (20/25 in 3, 20/40 in 1, and 20/50 in 1) and 2 had reduced vision from submacular hemorrhage., Conclusions: The PDS provides excellent control of exudation in the fovea in patients with neovascular age-related macular degeneration, and when exudation occurs, it often resolves without a negative impact on vision., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To report 2-year results from the Archway clinical trial of the Port Delivery System with ranibizumab (PDS) for treatment of neovascular age-related macular degeneration (nAMD)., Design: Phase 3, randomized, multicenter, open-label, active-comparator-controlled trial., Participants: Patients with previously treated nAMD diagnosed within 9 months of screening and responsive to anti-vascular endothelial growth factor therapy., Methods: Patients were randomized 3:2 to PDS with ranibizumab 100 mg/ml with fixed refill-exchanges every 24 weeks (PDS Q24W) or intravitreal ranibizumab 0.5 mg injections every 4 weeks (monthly ranibizumab). Patients were followed through 4 complete refill-exchange intervals (∼2 years)., Main Outcome Measures: Change in best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline averaged over weeks 44 and 48, weeks 60 and 64, and weeks 88 and 92 (noninferiority margin, -3.9 ETDRS letters)., Results: The PDS Q24W was noninferior to monthly ranibizumab, with differences in adjusted mean change in BCVA score from baseline averaged over weeks 44/48, 60/64 and 88/92 of -0.2 (95% confidence interval [CI], -1.8 to +1.3), +0.4 (95% CI, -1.4 to +2.1) and -0.6 ETDRS letters (95% CI, -2.5 to +1.3), respectively. Anatomic outcomes were generally comparable between arms through week 96. Through each of 4 PDS refill-exchange intervals, 98.4%, 94.6%, 94.8%, and 94.7% of PDS Q24W patients assessed did not receive supplemental ranibizumab treatment. The PDS ocular safety profile was generally unchanged from primary analysis. Prespecified ocular adverse events of special interest (AESI) were reported in 59 (23.8%) PDS and 17 (10.2%) monthly ranibizumab patients. The most common AESI reported in both arms was cataract (PDS Q24W, 22 [8.9%]; monthly ranibizumab, 10 [6.0%]). Events in the PDS Q24W arm included (patient incidence) 10 (4.0%) conjunctival erosions, 6 (2.4%) conjunctival retractions, 4 (1.6%) endophthalmitis cases, and 4 (1.6%) implant dislocations. Serum ranibizumab sampling showed that the PDS continuously released ranibizumab over the 24-week refill-exchange interval and ranibizumab serum concentrations were within the range experienced with monthly ranibizumab., Conclusions: The PDS Q24W showed noninferior efficacy to monthly ranibizumab through approximately 2 years, with approximately 95% of PDS Q24W patients not receiving supplemental ranibizumab treatment in each refill-exchange interval. The AESIs were generally manageable, with learnings continually implemented to minimize PDS-related AEs., Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references., (Copyright © 2023 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Aim: To quantify the areas of burden experienced by patients requiring repeated intravitreal injections (IVI) in the management of exudative retinal diseases., Methods: The validated Questionnaire to Assess Life Impact of Treatment by Intravitreal Injections survey was administered to patients at four retina clinical practices across four US states. The primary outcome measure was Treatment Burden Score (TBS), a single score assessing overall burden., Results: Of 1416 (n=657 age-related macular degeneration; n=360 diabetic macular oedema/diabetic retinopathy; n=221 retinal vein occlusion; n=178 other/uncertain) patients, 55% were women with an average age of 70 years. Patients most frequently reported receiving IVI every 4-5 weeks (40%). The mean TBS was 16.1±9.2 (range 1-48; scale of 1-54), and the TBS was higher in patients with diabetic macular oedema and/or diabetic retinopathy (DMO/DR) (17.1) compared with those with age-related macular degeneration (15.5) or retinal venous occlusive (15.3) (p=0.028). Though the mean level of discomfort was quite low (1.86) (scale 0-6), 50% of patients reported experiencing side effects more than half of the visits. Patients having received fewer than 5 IVI reported higher mean anxiety levels before (p=0.026), during (p=0.050) and after (p=0.016) treatment compared with patients having received more than 50 IVI. After the procedure, 42% of patients reported restrictions from usual activities due to discomfort. Patients reported a high mean satisfaction rating of 5.46 (scale 0-6) with the care of their diseases., Conclusions: The mean TBS was moderate and highest among patients with DMO/DR. Patients with more total injections reported lower levels of discomfort and anxiety but higher disruption to daily life. Despite the challenges related to IVI, the overall satisfaction with treatment remained high., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To evaluate the impact of anti-vascular endothelial growth factor therapy on the refractive error in eyes with diabetic macular edema., Methods: Post hoc analysis of Diabetic Retinopathy Clinical Research protocol T. Spherical equivalent (SE) was calculated for study and fellow eyes at baseline, 1-year, and 2-year visits. The SE change of the eyes with edema was compared with those with resolved edema. The correlation between refractive error changes and central subfield thickness was evaluated., Results: Among 543 study eyes, SE changed from -0.17 (2.04) D at baseline visit to -0.16 (2.14) D at 2 years giving a hyperopic shift of 0.04 (0.82) D (P = 0.022). Among fellow eyes, mean (SD) SE changed from -0.19 (2.1) D at baseline to -0.11 (2.1) D at 2 years, giving a hyperopic shift of 0.12 (0.84) D (P = 0.001). No significant difference in SE shift was found between eyes with and without edema at 2 years in phakic (0.12D and 0.08 D, P = 0.87) and pseudophakic eyes (-0.24D and -0.08D, P = 0.30). The SE shift was not correlated with central subfield thickness change at the end of the second year (r = 0.02, P = 0.62)., Conclusion: Diabetic macular edema patients have minimal changes in refractive error. The correction of refractive error may be considered during treatment, regardless of the presence of edema.

Purpose: To determine factors associated with loss of good vision (defined as Snellen visual acuity [VA] < 20/40) after surgery among eyes presenting with macula-on primary rhegmatogenous retinal detachment (RRD) with initial VA ≥20/40., Methods: Multicenter, retrospective, cohort study of eyes undergoing scleral buckle (SB), pars plana vitrectomy (PPV), or combined pars plana vitrectomy/scleral buckle (PPV/SB) for non-complex macula-on RRD with initial VA ≥20/40., Results: Among 646 eyes with macula-on RRDs with initial VA ≥20/40, 106 (16.4%) had VA <20/40 (i.e. lost good vision) at final follow-up. Eyes losing good vision had slightly worse pre-operative logMAR VA (mean 0.15 ± 0.10 [20/28]) compared to eyes that preserved good vision (mean 0.11 ± 0.10 [20/26]) (p = 0.004). RRDs extending greater than 6 clock-hours were more likely to lose good vision than smaller detachments (multivariate OR 4.57 [95% CI 1.44-14.51]; p = 0.0099). Compared to eyes repaired with SB alone, eyes undergoing PPV (multivariate OR 7.22 [95% CI 2.10-24.90]; p = 0.0017) or PPV/SB (multivariate OR 10.74 [95% CI 3.20-36.11]; p = 0.0001) were each more likely to lose good vision. Eyes requiring further RRD-related (multivariate OR 8.64 [95% CI 1.47-50.66]; p < 0.017) and non-RRD related vitreoretinal surgery (multivariate OR 14.35 [95% CI 5.39-38.21]; p < 0.0001) were more likely to lose good vision., Conclusion: Among macula-on RRDs, loss of good vision was associated with worse vision on presentation, vitrectomy-based procedures, greater extent of detachment, and lack of single surgery success. Understanding predictors of visual outcome in macula-on RRD repair may guide pre-operative counseling regarding visual prognosis.

Purpose: To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD)., Design: Phase 3, open-label, randomized, visual acuity assessor-masked noninferiority and equivalence trial., Participants: Patients with nAMD diagnosed within 9 months of screening previously treated with and responsive to anti-vascular endothelial growth factor therapy., Methods: Patients were randomized 3:2 to treatment with the PDS with ranibizumab 100 mg/ml with fixed 24-week (Q24W) refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab)., Main Outcome Measures: Primary end point was change in best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter (letters) score from baseline averaged over weeks 36 and 40 (noninferiority margin,-4.5 letters; equivalence margin, ±4.5 letters)., Results: Archway enrolled 418 patients; 251 were randomized to and 248 received treatment with the PDS Q24W, and 167 were randomized to and received treatment with monthly ranibizumab. Baseline BCVA was 74.4 letters (PDS Q24W arm) and 75.5 letters (monthly ranibizumab arm; Snellen equivalent, 20/32). Adjusted mean change in BCVA score from baseline averaged over weeks 36 and 40 was +0.2 letters (standard error [SE], 0.5 letters) in the PDS Q24W arm and +0.5 letters (SE, 0.6 letters) in the monthly ranibizumab arm (difference, -0.3 letters; 95% confidence interval, -1.7 to 1.1 letters). PDS Q24W was both noninferior and equivalent to monthly ranibizumab. Of 246 PDS-treated patients assessed for supplemental ranibizumab treatment, 242 (98.4%) did not receive supplemental ranibizumab treatment before the first refill-exchange procedure, including 4 patients who discontinued treatment before the first refill-exchange procedure. Prespecified ocular adverse events of special interest were reported in 47 patients (19.0%) in the PDS Q24W arm and 10 patients (6.0%) in the monthly ranibizumab arm, which included, in the former arm, 4 (1.6%) endophthalmitis cases, 2 (0.8%) retinal detachments, 13 (5.2%) vitreous hemorrhages, 6 (2.4%) conjunctival erosions, and 5 (2.0%) conjunctival retractions. Most ocular adverse events in the PDS Q24W arm occurred within 1 month of implantation., Conclusions: Archway met its primary objective and PDS Q24W demonstrated noninferior and equivalent efficacy to monthly ranibizumab, with 98.4% of PDS-treated patients not receiving supplemental treatment in the first 24-week interval., (Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Background: 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)., Methods: 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)., Findings: 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%])., Interpretation: 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., Funding: F Hoffmann-La Roche., Competing Interests: Declaration of interests JSH reports support from Genentech/Roche for the present manuscript; grants from Apellis, AsclepiX, Bayer, Gyroscope, Hemera, Iveric Bio, Kanghong, Kodiak, NGM, Notal Vision, Novartis, Regeneron, Regenxbio, and Stealth, outside the submitted work; and consulting fees from Apellis, AsclepiX, Bayer, Gyroscope, Hemera, Iveric Bio, Kanghong, Kodiak, NGM, Notal Vision, Novartis, Regeneron, Regenxbio, and Stealth. AMK reports grants or contracts to institution from Adverum, Allergan, Chengdu Kanghong, Genentech, Graybug, Novartis, Ophthea, Regenxbio, and Roche, outside the submitted work; consulting fees from Adverum, Allergan, Chengdu Kanghong, Genentech, Graybug, Novartis, Ophthea, Regenxbio, and Roche, outside the submitted work; payment or honoraria for lectures, presentations, or speaker bureaus from Allergan, Genentech, and Novartis, outside the submitted work; and has served on advisory boards for Adverum, Allergan, Chengdu Kanghong, Genentech, Novartis, Ophthea, Regenxbio, and Roche. CQR is an employee of Genentech and reports owning stocks in Roche. KB is an employee of Roche Products (Ireland). PJF reports patient care grants to institution (Vitreoretinal Consultants of New York) for various national clinical trials from Alkeus, Apellis, Chengdu Kanghong, Genentech, Gyroscope, Iveric Bio, Kodiak, NGM, and Regeneron; has served on advisory boards for Allergan and Genentech; and is the president of the American Association of Retinal Specialists (unpaid). CB is an employee of Genentech, and reports owning stocks in Roche. MSF reports consulting fees from Alcon, Bayer, Novartis, Roche, and Zeiss. HL is an employee of Genentech, and has received stock from Genentech/Roche as an employee; has received support from Genentech/Roche to attend meetings as an employee; and is a coauthor on patent application WO202123804 involving the PTI algorithm. FGH reports research grants or contracts to institution from Bayer, Bioeq/Formycon, Kanghong, Novartis, and Roche/Genentech; consulting fees from Bayer, Kanghong, Novartis, and Roche/Genentech; and payment or honoraria for lectures, presentations, or speaker bureaus from Bayer and Novartis. VP is an employee of F Hoffmann-La Roche (UK). TYYL reports grants or contracts to institution from Bayer, Chengdu Kanghong, and Novartis, outside the submitted work; consulting fees from Bayer, Boehringer Ingelheim, Novartis, Oculis, and Roche, outside the submitted work; and payment or honoraria for lectures, presentations, or speaker bureaus from Bayer, Chengdu Kanghong, Novartis, and Roche, outside the submitted work. DS is an employee of F Hoffmann-La Roche (UK); owns stock and stock options in Roche; and is a coauthor on patent application WO202123804 involving the PTI algorithm. CR reports research support from Allergan, Kodiak, Novartis, and Regeneron, outside the submitted work; and consulting fees from Allergan, Genentech, Kodiak, and Novartis, outside the submitted work. BS is an employee of F Hoffmann-La Roche. FV reports consulting fees from Bayer and Roche; payments for expert testimony from Bayer and Roche; and payments for participation on advisory boards for Bayer and Roche. CMGC reports grants or contracts from Bayer, Boehringer Ingelheim, Novartis, and Topcon, outside the submitted work; consulting fees from Novartis and Roche, outside the submitted work; speaker fees from Allergan, Bayer, Novartis, Roche, Topcon, and Zeiss, outside the submitted work; and support for travel to meetings from Bayer and Topcon. TYW reports clinical trial grants from Aldropika, Allergan, Bayer, Boehringer Ingelheim, Eden Ophthalmic, Genentech, Iveric Bio, Merck, Novartis, Oxurion (ThromboGenics), Roche, Samsung, Shanghai Henlius, and Zhaoke, outside the submitted work; consulting fees from Aldropika, Allergan, Bayer, Boehringer Ingelheim, Eden Ophthalmic, Genentech, Iveric Bio, Merck, Novartis, Oxurion (ThromboGenics), Roche, Samsung, Shanghai Henlius, and Zhaoke, outside the submitted work; payment or honoraria from Allergan, Bayer, Boehringer Ingelheim, Eden Ophthalmic, Genentech, Iveric Bio, Merck, Novartis, Oxurion (ThromboGenics), Roche, Samsung, Shanghai Henlius, and Zhaoke, outside the submitted work; support for travel from Aldropika, Allergan, Bayer, Boehringer Ingelheim, Eden Ophthalmic, Genentech, Iveric Bio, Merck, Novartis, Oxurion (ThromboGenics), Roche, Samsung, Shanghai Henlius, and Zhaoke; and has served on advisory boards of Aldropika, Allergan, Bayer, Boehringer Ingelheim, Eden Ophthalmic, Genentech, Iveric Bio, Merck, Novartis, Oxurion (ThromboGenics), Roche, Samsung, Shanghai Henlius, and Zhaoke., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Introduction: Neovascular age-related macular degeneration (nAMD) is characterized by exudation of fluid from abnormally growing blood vessels in the macula. Anti-vascular endothelial growth factor (VEGF) therapy is standard treatment for nAMD. Fluid resolution is used both as an indicator of disease control and to guide the frequency of treatment because of anti-VEGF therapy effectiveness in reducing neovascularization-related exudation. Herein reports a post hoc assessment of the HAWK and HARRIER trials comparing the efficacy and safety of brolucizumab with aflibercept in patients with nAMD., Materials and Methods: HAWK randomized 1,078 patients with untreated, active choroidal neovascularization due to AMD in the study eye to receive brolucizumab 3, 6 mg or aflibercept 2 mg. In HARRIER, 739 patients received brolucizumab 6 mg or aflibercept 2 mg. Brolucizumab was injected at weeks 0, 4, and 8, and thereafter q12w unless disease activity was identified (injection interval: q8w). Aflibercept was injected q8w after the loading phase, aligned with approved dosing at study initiation. The objective of this analysis was to assess effects of brolucizumab versus aflibercept on retinal fluid resolution during two phase 3 trials (HAWK and HARRIER) in patients with nAMD. Anatomical assessments for intraretinal fluid (IRF) and subretinal fluid (SRF) were performed every 4 weeks by spectral domain optical coherence tomography. Sustained dryness was defined as a patient being fluid-free (SRF and IRF) on ≥3 consecutive visits. Time to sustained dryness was determined by Kaplan-Meier estimates., Results: At week 96, fluid resolution (absence of IRF and SRF) was achieved by more brolucizumab- (6 mg; 76.1%) versus aflibercept-treated patients (63.1%; p = 0.0002, HAWK); 75.4% versus 61.8% (p < 0.0001, HARRIER). More patients achieved sustained dryness with brolucizumab versus aflibercept: at 96 weeks, 87.9% (brolucizumab 3 mg) and 86.1% (brolucizumab 6 mg) versus 82.0% (aflibercept) in HAWK, and 91.2% (brolucizumab) versus 78.0% (aflibercept) in HARRIER. Sustained dryness was achieved faster and hence with fewer brolucizumab injections., Discussion/conclusion: Brolucizumab dried the macula in patients with nAMD faster and to a greater degree than aflibercept. Achieving sustained dryness faster, and therefore with fewer injections, provides an opportunity for earlier decisions relating to treatment interval extension potentially reducing treatment burden., (© 2022 S. Karger AG, Basel.)

Purpose: This work assesses the clinical characteristics and outcomes of various treatment methods in managing rhegmatogenous retinal detachments secondary to retinal dialysis., Methods: In this retrospective, consecutive case series, patients presenting to a tertiary referral vitreoretinal service from 2015 to 2020 were chosen. The primary outcome measure was the single-surgery anatomic success (SSAS) rate in the first 90 days after surgery and overall SSAS rate until the last visit., Results: Eighty-six eyes of 84 patients were included. Mean (SD) age was 30 (14.8) years (range, 7-71 years). Fifty-nine (70%) patients were men and 55 eyes (64%) had a history of trauma. Dialysis occurred in the inferotemporal quadrant in 50 eyes (58%) of the entire cohort and 25 of 55 eyes (45%) with prior trauma. Fifty-one eyes (59.3%) were managed by scleral buckle (SB), 25 eyes (29.2%) with laser retinopexy, and 10 eyes (11.6%) with pars plana vitrectomy (PPV). The SSAS rate in the first 90 days after surgery was 94.1% (81 of 86 eyes), including 90.1% of eyes with SB, 100% of eyes with laser retinopexy, and 100% of eyes with PPV ( P = .07). The overall SSAS rate, however, was 89.5% (77 of 86) eyes, including 90.1% of eyes with SB, 84% of eyes with laser retinopexy, and 100% of eyes with PPV ( P = .4). Final attachment rate was 100% in the entire cohort., Conclusions: With careful consideration of underlying pathology, all 3 treatment modalities can provide high rates of anatomic and functional success., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2021.)

Purpose: To compare 2 mg intravitreal triamcinolone (IVT) versus 40 mg posterior sub-Tenon triamcinolone acetonide (STT) for the treatment of eyes with pseudophakic cystoid macular edema., Methods: A retrospective, single-center review of eyes receiving 2 mg IVT between 3/1/2012-3/1/2017 and 40 mg STT between 1/1/2015-3/1/2017. Visual acuity (VA) and central macular thickness (CMT) were recorded at baseline, 1-, 3-, and 6-month follow-up visits., Results: Forty-five eyes were included in the IVT group and 50 eyes in the STT group. Change in VA from baseline to 1, 3, and 6 months was not significantly different between IVT and STT (6 months: 2.3 lines vs. 2.4 lines, p = .10). The IVT group achieved significantly better CMT improvement from baseline compared to STT at 1 month (255 μm vs. 187 μm; p = .03), but this difference was not present at month 3 (214 μm vs. 212 μm; p = .79) or month 6 (176 μm vs. 207 μm; p = .29). During the 6-month follow-up period, approximately 7% of eyes in the IVT group and 12% of eyes in the STT group developed ocular hypertension ( p = .43), and all cases were successfully managed with topical anti-ocular hypertensive therapy or observation., Conclusions: 2 mg IVT and 40 mg STT both achieved significant improvement in vision and CMT with no significant difference between interventions at 3- and 6-month follow-up.

Objective: To understand patient burden of treatment of repeated intravitreal injections (IVI) in the management of exudative retinal diseases., Methods and Analysis: Participants were sampled from a large urban retina specialty practice in Houston, Texas, USA, based on history of ongoing receipt of IVI. The 50-item Questionnaire to Assess Life Impact of Treatment by Intravitreal Injections questionnaire was developed to evaluate the patient experience including discomfort, anxiety, inconvenience and satisfaction. Categorial principal components analysis (CATPCA) was performed to assess construct validity and internal consistency. A subset of these items was used to establish a measure of total treatment burden, referred to as the IVI Treatment Burden Score (TBS)., Results: 142 patients participated in this study. CATPCA analysis revealed five dimensions of patient burden: disruption of normal routine or capacity, anxiety, frequency of visits, chronicity of disease and perceived treatment value or satisfaction. Together, these dimensions accounted for 67% of variance explained. Cronbach's alpha was 0.97. The most frequently cited cause of discomfort was the feeling after anaesthetic wore off. The most common source of anxiety was fear of injection and associated discomfort or pain. Regarding inconvenience, patients reported temporary postinjection debilitation, requiring an average of 8 hours for recovery per treatment. The most frequently identified sources of satisfaction were confidence in the provider or treatment and interactions with staff., Conclusions: Understanding and quantifying the patient burden associated with repeated IVI for exudative retinal diseases can reveal opportunities to improve delivery methods. The TBS could serve to inform strategies to maximise treatment adherence and optimise patient experiences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background/aims: Vitrectomy to repair retinal detachment is often performed with either non-contact wide-angle viewing systems or wide-angle contact viewing systems. The purpose of this study is to assess whether the viewing system used is associated with any differences in surgical outcomes of vitrectomy for primary non-complex retinal detachment repair., Methods: This is a multicenter, interventional, retrospective, comparative study. Eyes that underwent non-complex primary retinal detachment repair by either pars plana vitrectomy (PPV) alone or in combination with scleral buckle/PPV in 2015 were evaluated. The viewing system at the time of the retinal detachment repair was identified and preoperative patient characteristics, intraoperative findings and postoperative outcomes were recorded., Results: A total of 2256 eyes were included in our analysis. Of those, 1893 surgeries used a non-contact viewing system, while 363 used a contact lens system. There was no statistically significant difference in single surgery anatomic success at 3 months (p=0.72), or final anatomic success (p=0.40). Average postoperative visual acuity for the contact-based cases was logMAR 0.345 (20/44 Snellen equivalent) compared with 0.475 (20/60 Snellen equivalent) for non-contact (p=0.001). After controlling for numerous confounding variables in multivariable analysis, viewing system choice was no longer statistically significant (p=0.097)., Conclusion: There was no statistically significant difference in anatomic success achieved for primary retinal detachment repair when comparing non-contact viewing systems to contact lens systems. Postoperative visual acuity was better in the contact-based group but this was not statistically significant when confounding factors were controlled for., Competing Interests: Competing interests: All disclosures are listed in the manuscript., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To compare rates of ocular hypertension (OHT) in eyes receiving 40 mg sub-Tenon triamcinolone (STT), 0.7 mg dexamethasone implant (DEX), and 2 mg intravitreal triamcinolone (IVT)., Methods: This study is a single-centre, retrospective case series. All patients receiving STT and DEX between 4/1/2014 and 3/1/2017 and IVT between 3/1/2012 and 3/1/2017 with a minimum of 3 months' follow-up were included. OHT was defined as an intraocular pressure (IOP) >24 mm Hg. Patients receiving any other form of topical, oral, or intravitreal steroid were excluded., Results: 113 eyes from 104 patients in the STT group, 122 eyes from 109 patients in the DEX group, and 109 eyes from 103 patients in the IVT group were included. The mean number of injections for each eye was 1.7 in the STT group, 2.6 for the DEX group, and 2.8 for the IVT group (p < 0.001). Twenty eyes (17.7%) developed OHT in the STT group, 19 eyes (15.6%) developed OHT in the DEX group, and 14 eyes (12.8%) developed OHT in the IVT group (p = 0.60). IOP was controlled in all eyes with observation, topical IOP-lowering medication, or surgical intervention. The rate of incisional glaucoma surgery was 1.7% in the STT group, 1.6% in the DEX group, and 0% in the IVT group (p = 0.55)., Conclusions: The rate of OHT was similar across treatment groups. The proportion of OHT in patients with a history of glaucoma was no different from that in patients without a history of glaucoma. All cases were successfully managed with observation, medical treatment, or incisional surgery., (Copyright © 2020 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.)

Purpose: This article compares 2-mg intravitreal triamcinolone (IVT) and 0.7-mg dexamethasone (DEX) implant for the treatment of diabetic macular edema in eyes that had a suboptimal response to antivascular endothelial growth factor therapy., Methods: A single-center, retrospective review was conducted of patients receiving either IVT between January 1, 2013, and January 1, 2018, or patients receiving DEX between October 1, 2015, and January 1, 2018. Visual acuity and central macular thickness (CMT) were recorded at visit of first injection and all subsequent visits., Results: Twenty-five eyes were included in the DEX group and 32 eyes were included in the IVT group. Change in vision from baseline was similar between DEX and IVT at 6-month follow-up (1.1 lines vs 2.3 lines, respectively; P = .24). Mean decrease in CMT from baseline was not different at 6-month follow-up (DEX: 120 µm vs IVT: 185 µm; P = .17)., Conclusions: DEX and 2-mg IVT both achieved improvement in vision and CMT with no significant differences between treatment groups at 6-month follow-up., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2020.)

Background : To compare the incidence and outcomes of ocular hypertension (OHT) after intravitreal injection of 0.7 mg dexamethasone (DEX) and 2 mg triamcinolone acetonide (IVT). Methods : In a single-center, retrospective comparative case series, all patients with at least 3 months follow-up receiving 2 mg IVT 3/1/2012 - 3/1/2017 or 0.7 mg dexamethasone 10/1/2014 - 3/1/2017 were included. Ocular hypertension was defined as an intraocular pressure (IOP) ≥ 25 mmHg. Patients with a minimum of 3 months follow-up were included. Patients receiving any other form of topical, oral, or intravitreal steroid were excluded. Results : 106 eyes in 100 patients receiving IVT and 114 eyes in 102 patients receiving DEX were included. The mean number of injections was 2.9 for patients receiving IVT and 2.4 for patients receiving DEX ( p = .11). Fourteen eyes (13.2%) in 14 patients receiving IVT developed OHT compared to 17 eyes (15.1%) in 15 patients receiving DEX ( p = .85). All cases of OHT were managed with IOP lowering drops or observation alone. Conclusions : Rates of ocular hypertension following 2 mg IVT and DEX are similar. All patients developing OHT were successfully managed without surgical intervention.