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PURPOSE: To assess the long-term safety and vision change in patients who received intravitreal aflibercept injection (IAI) for neovascular age-related macular degeneration in an extension study after completing VIEW 1 trial. DESIGN: Prospective, open-label, multicenter, extension study. PARTICIPANTS: Three hundred twenty-three patients. METHODS: In VIEW 1, 1217 patients were randomized to receive fixed dosing of 0.5 mg IAI every 4 weeks (0.5q4), 2 mg IAI every 4 weeks (2q4), 2 mg IAI every 8 weeks after 3 initial monthly dosing (2q8), or 0.5 mg ranibizumab every 4 weeks (Rq4) from baseline through week 52, followed by modified quarterly injections of the same dose of anti-vascular endothelial growth factor agent from weeks 52 to 96. After completing VIEW 1 at week 96, patients (n = 323) enrolled in an extension study and received 2 mg IAI on a modified quarterly injection schedule followed by at least an every 8-week dosing through week 212. MAIN OUTCOME MEASURES: Long-term safety and vision change in patients followed for a median duration of 116 weeks in the extension study (total follow-up time of 212 weeks from the VIEW 1 baseline). RESULTS: Patients enrolled in the extension study gained a mean of 10.2 letters from the VIEW 1 baseline at week 96. These patients largely maintained vision over the extension study with a mean gain of 7.1 letters from the VIEW 1 baseline to week 212. The proportion of patients who lost ≥15 letters from the VIEW 1 extension baseline was 8.2% at week 212. Mean number of injections was 12.9 (range, 1-41) in the extension study. The most common serious ocular adverse event was endophthalmitis (0.9%). The overall incidence of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events was 6.2%. CONCLUSIONS: Vision gains achieved with anti-vascular endothelial growth factor therapy in VIEW 1 were largely maintained by continued treatment with IAI 2 mg in the extension study. Anti-vascular endothelial growth factor injections (including 4 years of IAI 2 mg) were well-tolerated with no new safety signals compared with the known profile of IAI.
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IMPORTANCE: Information on the effect of anti-vascular endothelial growth factor therapy in eyes with diabetic macular edema (DME) with vision loss after macular laser photocoagulation is clinically valuable. OBJECTIVE: To evaluate visual and anatomic outcomes in a subgroup of macular laser photocoagulation treatment control (hereafter laser control) eyes with substantial vision loss receiving treatment with intravitreal aflibercept injection. DESIGN, SETTING, AND PARTICIPANTS: This investigation was a post hoc analysis of a subgroup of laser control eyes in 2 phase 3 trials-VISTA (Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema) and VIVID (Intravitreal Aflibercept Injection in Vision Impairment Due to DME)-in a multicenter setting. One hundred nine laser control eyes with center-involving DME were included. INTERVENTIONS: Treatment with intravitreal aflibercept injection (2 mg) every 8 weeks after 5 monthly doses with sham injections on nontreatment visits starting at week 24 was initiated on meeting prespecified criteria of at least a 10-letter visual acuity loss at 2 consecutive visits or at least a 15-letter visual acuity loss from the best previous measurement at 1 visit and vision not better than at baseline. MAIN OUTCOMES AND MEASURES: Visual and anatomic outcomes in a subgroup of laser control eyes receiving treatment with intravitreal aflibercept injection. RESULTS: Through week 100, a total of 63 of 154 eyes (40.9%) in VISTA and 46 of 133 eyes (34.6%) in VIVID initially randomized to laser control received treatment with intravitreal aflibercept injection. The median time from week 24 to the first intravitreal aflibercept injection treatment was 34.0 (VISTA) and 83.5 (VIVID) days. In this subgroup, the mean (SD) visual gain from baseline to week 100 was 2.2 (12.5) (VISTA) and 3.8 (10.1) (VIVID) letters. At the time of intravitreal aflibercept injection initiation, these eyes had a mean (SD) loss of 11.0 (10.1) (VISTA) and 10.0 (6.5) (VIVID) letters from baseline, and they subsequently gained a mean (SD) of 17.4 (9.7) (VISTA) and 13.6 (8.6) (VIVID) letters from the initiation of treatment with intravitreal aflibercept injection through week 100. There was a minimal mean change in central subfield thickness from baseline in these eyes at the time of intravitreal aflibercept injection initiation (an increase of 3.9 µm in VISTA and a decrease of 3.0 µm in VIVID), after which further mean (SD) reductions of 285.6 (202.6) µm (VISTA) and 313.4 (181.9) µm (VIVID) occurred through week 100. CONCLUSIONS AND RELEVANCE: Intravitreal aflibercept injection improves visual and anatomic outcomes in eyes experiencing substantial vision loss after macular laser photocoagulation treatment for DME. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01363440 and NCT01331681.
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PURPOSE: To examine the time burden of managing neovascular age-related macular degeneration (AMD) imposed on physicians, staff, patients, and caregivers. DESIGN: Mixed-methods, prospective, observational time-and-motion study. METHODS: The multicenter study was conducted from March 2011 through August 2012. Retina specialists administering ≥50 vascular endothelial growth factor (VEGF)-inhibitor injections monthly were surveyed and completed records for ≥5 patients scheduled for office visits within 3 weeks for anti-VEGF injection or monitoring. A survey was administered to 75 neovascular AMD patients aged ≥50 years who received ≥1 anti-VEGF injection in the past 6 months. Telephone interviews were conducted with 13 neovascular AMD patient caregivers. RESULTS: Fifty-six physicians provided data for 221 patients with neovascular AMD. Patients accounted for 20% of the health care staff's time per week, with an average of 23 staff members. An average patient visit for neovascular AMD was 90 minutes (range: 13 minutes to >4 hours). Patients reported an average time per visit of almost 12 hours, including preappointment preparation (16 minutes), travel (66 minutes), waiting time (37 minutes), treatment time (43 minutes), and postappointment recovery (9 hours). Patients stated that caregivers took time away from work (22%) and personal activities (28%) to provide transportation to appointments. CONCLUSIONS: Neovascular AMD management imposes a substantial time burden on physicians, staff, patients, and caregivers. There may be a need for additional support and/or reimbursement for services required by patients and caregivers and provided by physicians.
