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RecruitingPhase 3NCT07064759

Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

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Trial Parameters

ConditionNeovascular Age-Related Macular Degeneration (nAMD)
Sponsor4D Molecular Therapeutics
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment480
SexALL
Min Age50 Years
Max AgeN/A
Start Date2025-07-22
Completion2028-11
Interventions
4D-150 IVT (3E10 vg/eye)EYLEA® (aflibercept) Injection 2 mg (0.05mL)

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Brief Summary

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Eligibility Criteria

Inclusion Criteria: * ≥50 years of age at time of consent * MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator * Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center * Demonstrated clinical response to aflibercept and functional stability in the study eye as confirm

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