Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

Summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: * To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response * To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Timeline

Start

2020-06-29

Primary completion

2022-05-30

Completion

2024-06-18

Publications

• Loewenstein A, Schmidt-Ott U, Do DV, Lanzetta P, Leal S, Berliner AJ, Chu KW, Barakat MR, Ghorayeb G, Stewart MW, Spitzer MS, Zhang X, McCullough A, Tueckmantel C, Avila D, Morgan-Warren P, Brunck L, Dupljak A, Hymowitz M, Portnoy A, Gale R. Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg: A 96-Week Pooled Analysis from PULSAR and PHOTON. Ophthalmol Ther. 2026 Jul;15(7):2441-2456. doi: 10.1007/s40123-026-01424-y. Epub 2026 Jun 13.
• Suzuma K, Murata T, Shimura M, Yoshida S, Kishino G, Berliner AJ, Chu KW, Reed K, Vitti R, Cheng Y, Voronca D, Bhore R, Leal S, Morgan-Warren P, Schulze A, Schmidt-Ott U, Kobayashi M, Sakamoto T; PHOTON Investigators. Intravitreal aflibercept 8 mg in patients from Japan with diabetic macular edema: 48-week subgroup analysis of the PHOTON trial. Jpn J Ophthalmol. 2026 Jan;70(1):123-138. doi: 10.1007/s10384-025-01271-7. Epub 2025 Dec 26.
• Do DV, Wykoff CC, Sivaprasad S, Brown DM, Boyer DS, Sakamoto T, Win P, Joshi S, Salehi-Had H, Seres A, Berliner AJ, Leal S, Vitti R, Chu KW, Reed K, Cheng Y, Bhore R, Bai Z, Schmidt-Ott U, Schmelter T, Schulze A, Hasanbasic Z, Morgan-Warren PJ, Zhang X, Hirshberg B, Yancopoulos GD; PHOTON Investigators. Intravitreal Aflibercept 8 mg for Diabetic Macular Edema: Ninety-Six-Week Results from the Randomized Phase 2/3 PHOTON Trial. Ophthalmology. 2026 May;133(5):577-588. doi: 10.1016/j.ophtha.2025.10.028. Epub 2025 Nov 10.
• Brown DM, Boyer DS, Do DV, Wykoff CC, Sakamoto T, Win P, Joshi S, Salehi-Had H, Seres A, Berliner AJ, Leal S, Vitti R, Chu KW, Reed K, Rao R, Cheng Y, Sun W, Voronca D, Bhore R, Schmidt-Ott U, Schmelter T, Schulze A, Zhang X, Hirshberg B, Yancopoulos GD, Sivaprasad S; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024 Mar 23;403(10432):1153-1163. doi: 10.1016/S0140-6736(23)02577-1. Epub 2024 Mar 7.

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Indications