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Purpose To better characterize visual function decline and geographic atrophy (GA) progression secondary to age-related macular degeneration (AMD). Design Proxima A (NCT02479386)/Proxima B (NCT02399072) were global, prospective, noninterventional, observational clinical trials. Participants Eligible patients were aged ≥50 years. Patients in Proxima A had bilateral GA without choroidal neovascularization (CNV) in either eye (N = 295). Patients in Proxima B had GA without CNV in the study eye and CNV±GA in the fellow eye (fellow eye CNV cohort, n = 168) or GA without CNV in the study eye, no CNV/GA in the fellow eye (fellow eye intermediate AMD cohort, n = 32). Methods Changes in visual function and imaging/anatomic parameters were evaluated over time using a mixed model for repeated measurement accounting for key baseline characteristics. Main Outcome Measures Prespecified end points included change in GA area from baseline, best-corrected visual acuity (BCVA) score assessed by Early Treatment Diabetic Retinopathy Study (ETDRS), and visual acuity under low-luminance (LLVA). Results At 24 months, adjusted mean (standard error) change in GA lesion area from baseline was 3.87 (0.15) mm2 in participants with bilateral GA (Proxima A), 3.55 (0.16) mm2 in the fellow eye CNV cohort (Proxima B), and 2.96 (0.25) mm2 in the fellow eye intermediate AMD cohort (Proxima B). Progression of GA was greater in patients with baseline nonsubfoveal (vs. subfoveal) GA lesions and tended to increase as baseline low-luminance deficit increased (all patients). Conversion to GA or CNV in the fellow eye occurred in 30% and 6.7% of participants, respectively, in the Proxima B intermediate AMD cohort at month 12. Adjusted mean (standard error) changes in BCVA and LLVA (ETDRS letters) in the study eye from baseline to 24 months were −13.88 (1.40) and −7.64 (1.20) in Proxima A, −9.49 (1.29) and −7.57 (1.26) in Proxima B fellow eye CNV cohort, and −11.48 (3.39) and −8.37 (3.02) in Proxima B fellow eye intermediate AMD cohort, respectively. Conclusions The prospective Proxima A and B studies highlight the severe functional impact of GA and the rapid rate of GA lesion progression over a 2-year period, including in patients with unilateral GA at baseline.

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.

PURPOSE To present visual acuity (VA) and related findings from patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of subfoveal choroidal neovascularization secondary to age-related macular degeneration (SST Group N Trial). DESIGN Randomized clinical trial. PARTICIPANTS Eligible patients had age-related macular degeneration with subfoveal choroidal neovascularization, some with a classic pattern on fluorescein angiography, and best-corrected VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no treatment in the macula. Any contiguous blood had to account for

Purpose To evaluate the anatomic closure rate and visual outcome in patients undergoing pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling with and without indocyanine green (ICG) enhancement. Design Retrospective, noncomparative interventional case series. Participants One hundred ninety-three consecutive patients (204 eyes) seen at the Barnes Retina Institute with the clinical diagnosis of macular hole who underwent PPV between January 1998 and December 2000. Intervention A consecutive series of 97 patients undergoing PPV with or without unilateral epiretinal membrane removal without ILM peeling (group 1), 44 patients with PPV and ILM peeling without ICG (group 2), and 35 patients with ICG-assisted ILM peeling (group 3). Results Overall, 86.4% of the holes closed with one operation, with 75 of 97 (77.3%) eyes in group 1, 43 of 44 (97.7%) eyes in group 2, and 34 of 35 (97.1%) eyes in group 3 (χ 2 = 10.51, P = 0.007). Of the eyes that did not close, 18 patients in group 1 underwent repeat surgery, with 90 of 97 (92.8%) eyes ultimately achieving closure. Visual acuity after surgery was 20/50 or better in 55 of 97 (56.7%) patients, 31 of 44 (70.4%) patients, and 18 of 35 (51.4%) patients in groups 1, 2, and 3, respectively (χ 2 = 3.43, P = 0.18) and increased by 2 or more lines from their preoperative status in 63 of 97 (64.9%) patients, 34 of 44 (77.3%) patients, and 25 of 35 (71.4%) patients, respectively (χ 2 = 2.25, P = 0.32). Multivariate logistic regression demonstrated that use of ILM peeling during vitrectomy increases the chances of developing 20/50 vision or better (odds ratio [OR], 2.4; 95% confidence interval, 1.06–5.45; P = 0.04). No eyes received concurrent cataract extraction with macular hole surgery, but 75 of 166 (45.2%) required cataract extraction postoperatively. Complications included 20 retinal tears, 4 retinal detachments, and 34 patients with postoperative elevations in intraocular pressure (IOP; defined as IOP greater than 30 mmHg). Conclusions Although this study is limited by the shorter follow-up in patients undergoing ILM peeling with or without ICG relative to the control group, our experience indicates that the use of ILM peeling is associated with a statistically significant improvement in the rate of primary macular hole closure with a single operation.

Objective This study aimed to report the visual outcome of surgical removal of extensive peripapillary choroidal neovascularization (CNV) due to presumed ocular histoplasmosis syndrome (POHS). Design Retrospective review of the records of all patients seen at the Barnes Retina Institute who underwent surgical removal of extensive peripapillary CNV associated with POHS and who had at least 12 months of follow-up. Participants Seventeen consecutive eyes (in 14 patients) undergoing surgical removal of extensive peripapillary CNV associated with POHS were studied. Intervention Pars plana vitrectomy and surgical removal of CNV were performed. Main outcome measurements Best-corrected Snellen visual acuity, funduscopic examination, and intravenous fluorescein angiography were obtained before surgery and at regular intervals after surgery. Results In 14 of 17 eyes, the peripapillary CNV was subfoveal, and in 3 eyes, it was extrafoveal. All three eyes with extrafoveal CNV were not eligible for laser treatment according to Macular Photocoagulation Study guidelines because treatment would have spared less than 1.5 contiguous clock-hours of retina temporal to the optic disc. Follow-up ranged from 17 to 57 months, with a median of 32 months. In eyes with subfoveal CNV, best-corrected preoperative Snellen visual acuity ranged from 20/25 to counting fingers at 2 feet with a median of 20/200, and best-corrected final Snellen visual acuity ranged from 20/25 to 20/200 with a median of 20/40. In 7 (50%) of 14 eyes, a final Snellen acuity of 20/40 or better was achieved, and in all cases except 1, visual acuity improved or did not change with surgery. In the three eyes with extrafoveal CNV, best-corrected preoperative Snellen visual acuity ranged from 20/20 to 20/400 with a median of 20/200, and best-corrected final Snellen visual acuity was 20/20 in all cases. In addition, visual acuity improved with surgery. Conclusions The data from this small retrospective study suggest that surgical removal may provide visual benefit in selected cases of extensive peripapillary CNV due to POHS.

Purpose: The authors assess the stability of visual acuity outcomes after the surgical removal of subfoveal choroidal neovascularization in a large series of patients with presumed ocular histoplasmosis syndrome (PONS). Methods: A retrospective study of 117 consecutive patients undergoing vitrectomy between February 1990 and December 1994 was performed. All patients underwent the surgical removal of subfoveal choroidal neovascularization due to POHS and had at least 3 months of follow-up. Postoperative Snellen visual acuity was the primary study endpoint. Results: With a median follow-up of 13 months (range, 3–46 months), 35% of patients had postoperative visual acuity of 20140 or better, and 40% had improvement of three or more Snellen lines after surgery. In a subset of 54 eyes followed for at least 1 year, 91% showed stable or improved vision between the 3- and 12-month time points, and 85% showed stable or improved vision between 3 months and final visit. Conclusion: Follow-up of a large number of patients appears to confirm initially encouraging results and to suggest stability of beneficial effect after the surgical removal of subfoveal choroidal neovascularization in POHS.

Purpose To report the long-term visual outcomes of surgical removal of extensive peripapillary choroidal neovascularization associated with presumed ocular histoplasmosis syndrome (POHS). Design Long-term retrospective review. Follow-up ranged from 14 to 139 months (mean, 68). Participants Forty consecutive eyes (in 35 patients) undergoing surgical removal of extensive peripapillary choroidal neovascularization associated with POHS at the Barnes Retina Institute between May 1992 and December 2003 were included in this review. Patient age ranged from 5 to 73 years (median, 34.5). All eyes were ineligible for laser treatment by Macular Photocoagulation Study criteria. Intervention Pars plana vitrectomy and surgical removal of choroidal neovascularization were performed. Main Outcome Measures Determination of Snellen best-corrected visual acuity (BCVA), funduscopic examination, and intravenous fluorescein angiography were done before surgery and at regular intervals after surgery. Results In the 23 eyes with subfoveal extension of peripapillary choroidal neovascularization, preoperative BCVA ranged from 20/25 to counting fingers (CF) at 2 feet (median, 20/200). Final postoperative BCVA ranged from 20/15 to CF at 2 feet (median, 20/50). Of 23 eyes, 18 achieved stable or improved BCVA from the preoperative to the final postoperative examination; only 5 eyes had ≥2 lines of decreased BCVA. Overall, 11 of 23 eyes achieved ≥20/40 BCVA at the final postoperative examination. In the 17 eyes in which choroidal neovascularization remained extrafoveal, preoperative BCVA ranged from 20/20 to 20/400 (median, 20/60). Final BCVA ranged from 20/20 to 20/200 (median, 20/20). Of 17 eyes, 15 achieved stable or improved BCVA from preoperative to final postoperative examination; only 2 eyes had ≥2 lines of decreased BCVA. Overall, 14 of 17 eyes achieved ≥20/40 BCVA at the final postoperative examination. Conclusions The data from this small retrospective study suggest that surgical removal may provide visual benefit in selected cases of extensive peripapillary choroidal neovascularization associated with POHS. Surgical removal of extensive peripapillary choroidal neovascularization does appear preferable to photoablation. Given the likelihood of multiple treatments with photodynamic therapy or anti–vascular endothelial growth factor therapies, surgical removal provides a potentially efficacious treatment with low recurrence rates and good visual results.

PURPOSE: To describe and compare methods used to monitor development and progression of presumed vision-limiting lens opacity in study eyes of Submacular Surgery Trials (SST) patients. DESIGN: Prospective study of patients enrolled in a set of randomized clinical trials. PARTICIPANTS: Patients enrolled in the SST who were phakic in the study eye at the time of enrollment (n = 690). In a subset of 114 patients, lens photographs were obtained at baseline and 2 years after enrollment. METHODS: Data collection at baseline and annual follow-up examinations included ocular history, ophthalmologic examination including the SST ophthalmologist's assessment of presence or absence of vision-limiting opacity, fundus photography, and lens photography (13 of 27 clinics only). All photographs were assessed by masked graders centrally using the Lens Opacities Classification System III (LOCS III). kappa statistics were calculated to compare LOCS III cataract classifications with fundus photograph quality and with the ophthalmologist's assessment of lens opacity, with the LOCS III classification considered the gold standard. MAIN OUTCOME MEASURE: Incidence of cataract in study eyes. RESULTS: Baseline lens photographs were available and graded for 312 (45%) of 690 patients with phakic study eyes; 2-year lens photographs were available for 156 (23%) of 690 initially phakic eyes. Both baseline and 2-year lens photographs were available for 114 eyes that remained phakic. Submacular surgery was associated with significant progression of nuclear color and nuclear opalescence characteristics within 2 years of enrollment. The reliability of fundus photograph quality versus cataract classification using a 4.5 LOCS III score threshold for cataract was poor to good at each time point and for all groups (kappa, 0-0.51), but sensitivity of the photograph quality score as a surrogate was low, and both positive and negative predictive values were low. Agreement between the ophthalmologists' assessments of lens opacity and the 4.5 LOCS III score threshold for cataract was good (kappa, 0.42-0.78). CONCLUSIONS: In the SST, clinical identification of severe cataract (LOCS III scores of 4.5 or worse for nuclear opacity or nuclear color) by the examining ophthalmologist was valid based on comparison with LOCS III scores and may be an adequate method to use in similar trials.