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

Launched by 4D MOLECULAR THERAPEUTICS · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 4D-150 for people with a condition called macular neovascularization (MNV), which happens as a complication of age-related macular degeneration (AMD), a common eye disease that can affect vision. The study aims to see how well a single injection of 4D-150 works compared to other treatments in adults who have this condition.

People who might be eligible to join are adults 50 years or older who have MNV related to AMD. They can either be new to treatment or have had no more than four previous injections of similar medications within the last six months, showing some improvement and stable vision. Participants will have certain eye features confirmed by imaging tests, and their vision needs to be within a specific range. During the trial, participants can expect to receive a single injection in the eye and have regular check-ups to monitor their response and eye health. It’s important to note that people with other serious eye problems, recent major illnesses, or certain heart conditions may not be able to take part. This study is currently recruiting volunteers who meet these criteria.

Gender

ALL

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 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 Criteria:
• 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:
• • 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
• • Uncontrolled blood pressure
• • 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