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INTRODUCTION The purpose was to compare two flexible regimens of intravitreal aflibercept (IVT-AFL) with fixed dosing every 8 weeks, beyond the first year of treatment, in patients with diabetic macular edema (DME). VIOLET was a 100-week, randomized, Phase IIIb, non-inferiority study in patients with center-involving DME previously treated with IVT-AFL for ≥ 1 year according to the European label. METHODS Patients received an initial dose of IVT-AFL at study baseline and were randomly assigned (1:1:1) to treat-and-extend (T&E), pro re nata (PRN), or fixed regimens. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (randomization) to Week 52. RESULTS Full analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72.7 letters in the T&E, PRN, and fixed-dose groups, respectively). Patients received a mean (min-max) of 10.0 (2-14; T&E), 11.5 (1-25; PRN), and 12.3 (3-13; fixed) injections over 100 weeks, with 13.3 (4-23), 25.0 (3-29), and 16.1 (5-25) clinic visits, respectively. At Week 52, mean (± standard deviation) BCVA changes from baseline were + 0.5 ± 6.7 (T&E), + 1.7 ± 6.8 (PRN), and + 0.4 ± 6.7 (fixed-dosing) letters (least squares mean difference [95% confidence interval]: T&E 0.01 [- 1.46, 1.47] and PRN 0.95 (- 0.52, 2.42) letters versus fixed dosing; p

Purpose To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). Design AQUA was a multicenter, open-label, single-arm, phase 4 study. Participants Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. Methods Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. Main Outcome Measures The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. Results A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was –175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. Conclusions Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept.

Purpose To assess the prevalence of vitreoretinal interface abnormalities in a general population of healthy adults ≥45 years of age. Design Cross-sectional study carried out at 17 ophthalmology services throughout Spain. Participants Between September 2015 and March 2016, all consecutive healthy persons aged ≥45 years who were accompanying patients to ophthalmology services were invited to take part in the study. Exclusion criteria were known retinal disease, uveitis, history of ocular trauma or previous intraocular surgery (including cataract surgery and intravitreal injections), severe myopia (>−6 dioptres), and poor ocular media transparency. Methods Spectral-domain OCT or swept-source OCT was performed on all participants. Diseases of the vitreomacular interface were classified according to the OCT-based anatomic classification system of the International Vitreomacular Traction Study Group. All pathologic and borderline images as well as doubtful cases were evaluated blindly in a central reading center. Main Outcome Measures Prevalence of vitreomacular interface abnormalities (vitreomacular traction epiretinal membrane, lamellar hole). Results The study included 2257 participants with a mean age of 59.5 years (range 45–90), and a total of 4490 eyes (right eyes 2242, left eyes 2248). Vitreoretinal interface abnormalities were detected in 70 eyes, with a prevalence of 1.6%. Vitreomacular adhesion was observed in 1317 eyes (29.3%). Results of spectral-domain OCT or swept-source OCT examination were unrevealing in 3103 eyes. Vitreoretinal interface abnormalities were found in 61 participants, with a prevalence in the study population of 2.7%. Vitreomacular traction was observed in 14 participants (0.6%), epiretinal membrane in 44 (1.9%), and lamellar macular hole in 3 (0.1%). The prevalence of both vitreomacular traction and epiretinal membrane increased significantly with age. The presence of vitreoretinal interface abnormalities was unrelated to concomitant diabetes mellitus or hypertension. Conclusions An important percentage of healthy participants from the general population ≥45 years of age showed vitreoretinal interface abnormalities. Screening with OCT is advisable at any first routine consultation or preoperative assessment, particularly in older participants.

We present the ultrasound and optic coherence tomography follow-up of a presumed choroidal metastasis from a contralateral melanoma. A 53-year-old male was diagnosed with uveal melanoma with extraescleral extension in his left eye. A year later, the fundus examination revealed a flat, gray-green, pigmented choroidal lesion in the right eye. The ultrasonography showed a mass, almost flat, and all these findings were compatible with a choroidal melanocytic lesion with risk factors for growth. One month later, melanocytic skin lesions appeared on the scalp, as well as small tumors. Three months later, an ultrasonography on B scan showed a growth of the tumor size. The patient developed a progressive deterioration and died. Three possibilities can explain the occurrence of a choroidal pigmented tumor in the contralateral eye: first, bilateral primary choroidal melanomas; second, both choroidal tumors are metastatic in origin from an unknown primary melanoma; and third, the contralateral tumor is a metastatic tumor from the primary choroidal melanoma.

Purpose TO describe the results obtained in patients with neovascular age-related macular degeneration treated with ranibizumab 0.5 mg on an as-needed basis from the start after 1 year of follow-up. Methods Retrospective, consecutive interventional case series of patients with all angiographic types of neovascular age-related macular degeneration (mean baseline size, 3.4 disk areas) in a tertiary retinal center (Institut de la Màcula i la Retina; Barcelona, Spain). Main outcome was mean vision change; secondary outcomes were center retinal thickness change, number of injections, adverse events, and independent covariates associated with a good response. Results Mean visual acuity change was an increase of 1.3 letters (95% confidence interval −2.7 to +5.3), and difference between angiographic patterns did not reach statistical significance (p=0.30). A decrease in retinal thickness of 44.6 μm was identified (pConclusions As-needed treatment from the start achieved stabilization of visual acuity and a moderate decrease of retinal thickness with a low number of injections, but did not achieve the same efficacy as regular monthly injections.