Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

Summary

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Timeline

Start

2020-08-11

Primary completion

2022-07-27

Completion

2024-08-07

Publications

• Sun X, Dai H, Chen Y, Sun X, Tao L, Xiao J, Han M, Zhao M, Wang L, Schulze A, Schmidt-Ott UM, Zhao M, Zhang X, Wang Z, Leal S, Wei W; PULSAR investigators. Intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration from China: 48-week results from the PULSAR trial. Int J Retina Vitreous. 2026 Jun 26. doi: 10.1186/s40942-026-00876-5. Online ahead of print.
• 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.
• Chang A, Sun X, Iida T, Lai TYY, Wong TY, Cheung CMG, Lee WK, Zhang X, Schulze A, Schmidt-Ott UM, Zhao M, Hasanbasic Z, Leal S, Chen SJ; PULSAR study investigators. Intravitreal aflibercept 8 mg versus 2 mg in Asian patients with neovascular age-related macular degeneration: 48-week analysis of the Phase 3 PULSAR trial. Asia Pac J Ophthalmol (Phila). 2026 Jan-Feb;15(1):100278. doi: 10.1016/j.apjo.2026.100278. Epub 2026 Jan 8.
• Lee WK, Wong TY, Chen SJ, Sun X, Cheung CMG, Silva R, Ricci F, Zhang X, Machewitz T, Schulze A, Schmidt-Ott UM, Zhao M, Hasanbasic Z, Leal S, Iida T; PULSAR Study Investigators. Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy: Post Hoc Analysis of the PULSAR Randomized Clinical Trial. JAMA Ophthalmol. 2026 Feb 1;144(2):129-137. doi: 10.1001/jamaophthalmol.2025.5098.
• Korobelnik JF, Lanzetta P, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Sun X, Berliner AJ, Schulze A, Zhao M, Schmelter T, Schmidt-Ott U, Zhang X, Morgan-Warren P, Hasanbasic Z, Vitti R, Chu KW, Reed K, Bhore R, Cheng Y, Bai Z, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: Ninety-Six-Week Results from the Randomized Phase 3 PULSAR Trial. Ophthalmology. 2026 Jan;133(1):39-50. doi: 10.1016/j.ophtha.2025.08.022. Epub 2025 Aug 26.
• Lanzetta P, Korobelnik JF, Heier JS, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Xiaodong S, Berliner AJ, Schulze A, Schmelter T, Schmidt-Ott U, Zhang X, Vitti R, Chu KW, Reed K, Rao R, Bhore R, Cheng Y, Sun W, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024 Mar 23;403(10432):1141-1152. doi: 10.1016/S0140-6736(24)00063-1. Epub 2024 Mar 7.

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Indications