Tests 4D-150 eye injection against aflibercept in age-related macular degeneration
Compares one 4D-150 eye injection with aflibercept in adults with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Key facts
- Where
- Ancona, ItalySee the site
- Phase
- Phase 3
Where in Italy
- AOU delle MarcheAncona, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- 4D Molecular Therapeutics
- Trial code
- NCT07064759
- Record updated
- 19 October 2026
- Original description
This Phase 3 study is evaluating the safety and efficacy of 4D-150 versus aflibercept in participants with neovascular age-related macular degeneration (nAMD). Enrollment in the primary global cohort has been completed; Study centers in Japan remain open for enrollment for the Japan cohort.Read full original descriptionShow less
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration
This Phase 3 study is evaluating the safety and efficacy of 4D-150 versus aflibercept in participants with neovascular age-related macular degeneration (nAMD). Enrollment in the primary global cohort has been completed; Study centers in Japan remain open for enrollment for the Japan cohort.
Inclusion: ≥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:; Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR; 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 confirmed by the Reading Center; BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit; CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center.
Exclusion: Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye; Systemic Conditions and Considerations:; Major illness or major surgical procedure in the 28 days prior to the Screening Visit; Ocular Conditions:; MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter); History of retinal detachment in the study eye; History of or presence of active inflammation in either eye; Glaucoma or intraocular hypertension requiring more than 2 topical medications for control; Ocular Treatments/Interventions:; Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit; History of autoimmune condition that may predispose to the development of uveitis; Uncontrolled blood pressure.