TY - JOUR
T1 - Randomized Trial of Treat-and-Extend Intravitreal Aflibercept for Radiation Retinopathy
T2 - 1-Year Outcomes
AU - ARRT Study Group
AU - Corona, Stephanie Trejo
AU - Boone, Cecilia Villanueva
AU - Ali, Amna M.
AU - Moore, Chelsey
AU - Brown, Alexandra
AU - Munoz, Jose
AU - Aaberg, Thomas
AU - Schefler, Amy C.
N1 - Funding Information:
Supported by Regeneron Pharmaceuticals, Inc (Tarrytown, NY, USA). The sponsor or funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and decision to submit the manuscript for publication.
Publisher Copyright:
Copyright 2023 The Authors.
PY - 2023/6/1
Y1 - 2023/6/1
N2 - PURPOSE: Radiation retinopathy (RR)-related macular edema commonly causes poor visual acuity outcomes in patients previously treated with ocular radiation therapy. Current treatments are not US Food and Drug Administration (FDA)-approved and prior studies have variable outcomes. We performed a multicenter, prospective, randomized clinical trial to assess the safety and efficacy of 2 mg intravitreal aflibercept injections (IAIs) for the treatment of RR.METHODS: Thirty-nine eyes in 39 patients with RR-related macular edema causing vision loss were assigned randomly to cohorts (1:1 ratio) in which patients either did or did not receive a loading dose of 3 IAIs followed by a treat-and-extend regimen. The primary outcome measure was the mean Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA) change from baseline.RESULTS: Of the 39 randomized patients, 30 (76.9%) completed the year 1 follow-up visit. The overall mean BCVA change from baseline was 4.3 letters (P = 0.087), with 1.57 letters and 6.69 letters gained in cohorts 1 and 2, respectively (P = 0.31). There was a significant difference in central retinal thickness (CRT) from baseline to week 52 overall (484.4 µm to 326.5 µm) and within cohorts 1 (441.2 µm to 311.1 µm) and 2 (522.3 µm to 339.9 µm), respectively (P < 0.001). A total of 96.7% of the patients had visual acuity of 20/200 or better, and 30.0% improved 10 or more letters.CONCLUSIONS: Aflibercept may improve CRT and may prevent vision loss in patients with RR using a treat-and-extend regimen through 52 weeks of therapy. Larger, multicenter studies are needed to confirm these findings.
AB - PURPOSE: Radiation retinopathy (RR)-related macular edema commonly causes poor visual acuity outcomes in patients previously treated with ocular radiation therapy. Current treatments are not US Food and Drug Administration (FDA)-approved and prior studies have variable outcomes. We performed a multicenter, prospective, randomized clinical trial to assess the safety and efficacy of 2 mg intravitreal aflibercept injections (IAIs) for the treatment of RR.METHODS: Thirty-nine eyes in 39 patients with RR-related macular edema causing vision loss were assigned randomly to cohorts (1:1 ratio) in which patients either did or did not receive a loading dose of 3 IAIs followed by a treat-and-extend regimen. The primary outcome measure was the mean Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA) change from baseline.RESULTS: Of the 39 randomized patients, 30 (76.9%) completed the year 1 follow-up visit. The overall mean BCVA change from baseline was 4.3 letters (P = 0.087), with 1.57 letters and 6.69 letters gained in cohorts 1 and 2, respectively (P = 0.31). There was a significant difference in central retinal thickness (CRT) from baseline to week 52 overall (484.4 µm to 326.5 µm) and within cohorts 1 (441.2 µm to 311.1 µm) and 2 (522.3 µm to 339.9 µm), respectively (P < 0.001). A total of 96.7% of the patients had visual acuity of 20/200 or better, and 30.0% improved 10 or more letters.CONCLUSIONS: Aflibercept may improve CRT and may prevent vision loss in patients with RR using a treat-and-extend regimen through 52 weeks of therapy. Larger, multicenter studies are needed to confirm these findings.
KW - aflibercept
KW - anti-VEGF
KW - central retinal thickness (CRT)
KW - macular edema
KW - radiation retinopathy (RR)
KW - Receptors, Vascular Endothelial Growth Factor/therapeutic use
KW - Prospective Studies
KW - Intravitreal Injections
KW - Humans
KW - Macular Edema/diagnosis
KW - Treatment Outcome
KW - Angiogenesis Inhibitors
KW - Recombinant Fusion Proteins/therapeutic use
KW - Ranibizumab/therapeutic use
UR - http://www.scopus.com/inward/record.url?scp=85162784339&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85162784339&partnerID=8YFLogxK
U2 - 10.1167/iovs.64.7.35
DO - 10.1167/iovs.64.7.35
M3 - Article
C2 - 37351877
AN - SCOPUS:85162784339
SN - 0146-0404
VL - 64
SP - 35
JO - Investigative Ophthalmology and Visual Science
JF - Investigative Ophthalmology and Visual Science
IS - 7
M1 - 35
ER -