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Original Investigation
March 18, 2021

Intravitreal Aflibercept Injection vs Sham as Prophylaxis Against Conversion to Exudative Age-Related Macular Degeneration in High-risk Eyes: A Randomized Clinical Trial

Author Affiliations
  • 1Ophthalmic Consultants of Boston, Boston, Massachusetts
  • 2Retina Consultants of Houston, Houston, Texas
  • 3New Jersey Retina, New Brunswick, New Jersey
  • 4All Eyes Consulting, LLC, New York, New York
  • 5The Retina Institute, St Louis, Missouri
  • 6Boston Image Reading Center, Tufts Medical Center, Boston, Massachusetts
  • 7Retina Consultants of Houston, Retina Consultants of America, Blanton Eye Institute, Houston Methodist Hospital, Weill Cornell Medical College, Houston, Texas
  • 8Department of Ophthalmology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
  • 9Retina Vitreous Associates Medical Group, Los Angeles, California
JAMA Ophthalmol. 2021;139(5):542-547. doi:10.1001/jamaophthalmol.2021.0221
Key Points

Question  Can intravitreal aflibercept injection (IAI) be used as a prophylactic treatment against conversion to exudative age-related macular degeneration (eAMD) in high-risk eyes?

Findings  In a randomized, single-masked clinical trial of 128 patients at high risk for eAMD, there was no difference in the proportion of eyes converting to eAMD between the IAI (6 patients [9.5%]) and sham (7 patients [10.9%]) groups at month 24. Patients with eAMD for longer than 2 years in their fellow eye at baseline showed a lower conversion rate in the study eye compared with those with eAMD for no longer than 2 years in the fellow eye.

Meaning  Although these findings do not support IAI as a prophylactic against conversion to eAMD, such prophylaxis is needed.

Abstract

Importance  Anti–vascular endothelial growth factor (VEGF) agents may provide a prophylactic effect in high-risk eyes with intermediate dry age-related macular degeneration (AMD) against conversion to exudative AMD (eAMD), lowering the risk of vision loss.

Objective  To evaluate intravitreal aflibercept injection (IAI) as prophylaxis against the conversion to eAMD in high-risk eyes at 24 months.

Design, Setting, and Participants  This single-masked, sham-controlled, randomized clinical trial performed at 4 US clinical sites enrolled patients with intermediate AMD in 1 eye (study eye), defined as presence of more than 10 medium drusen (≥63 to <125 μm), at least 1 large druse (≥125 μm), and/or retinal pigmentary changes, and eAMD in the fellow eye. Patients were treated from June 23, 2015, to March 13, 2019.

Interventions  Intravitreal aflibercept injection (2 mg) or sham quarterly injection for 24 months (1:1 randomization).

Main Outcomes and Measures  The primary end point was the proportion of patients with conversion to eAMD at month 24 characterized by development of choroidal neovascularization, as assessed by leakage on fluorescein angiography and fluid on spectral-domain optical coherence tomography by an independent masked reading center.

Results  Of 128 patients enrolled, 127 (63 in the IAI group and 64 in the sham group) were included in the primary analysis (68 men [53.5%]; mean [SD] age, 76.5 [8.1] years). Baseline demographic and clinical characteristics were balanced between the groups. By month 24, 6 patients (9.5%) in the IAI group and 7 (10.9%) in the sham group developed eAMD (P = .98). Patients with a history of eAMD for longer than 2 years in their fellow eye at baseline showed a lower rate of conversion to eAMD in the study eye compared with those with a history of eAMD for 2 years or less in the fellow eye. Safety was consistent with previous studies involving intravitreal anti-VEGF injections.

Conclusions and Relevance  In this evaluation of quarterly anti-VEGF exposure as prophylaxis to reduce conversion of eyes with high-risk dry AMD to eAMD, the rates of conversion were not lower in the IAI group compared with the sham treatment group at month 24. Understanding the mechanism of conversion to eAMD and therapies that could prevent this event remains an important unmet need.

Trial Registration  ClinicalTrials.gov Identifier: NCT02462889

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