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
Outcome
Met primary endpoint
registry Difference in LS means -0.97 (95% CI -2.87 to 0.92) NCT04423718 ↗
registry Difference in LS means -1.14 (95% CI -2.97 to 0.69) NCT04423718 ↗
paper Aflibercept 8q12 and 8q16 showed non-inferior BCVA gains versus aflibercept 2q8 PMID 38461841 ↗
release “As presented at AAO, the PHOTON trial in DME and the PULSAR trial in wAMD both met the same primary endpoint.” regeneron.com ↗
release “the PULSAR trial in wAMD (N=1,009) met their primary endpoint, with aflibercept 8 mg demonstrating non-inferior vision gains at 48 weeks” regeneron.com ↗
release “PULSAR clinical trial in nAMD and the PHOTON trial in DME. Both studies met their primary endpoint of non-inferior best corrected visual acuity” bayer.com ↗
release “PULSAR clinical trial in nAMD and the PHOTON trial in DME. Both studies met their primary endpoint” bayer.com ↗
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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Subject | Aflibercept | Protein / enzyme biologic | 8 mg | Intravitreal |