4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Launched by 4D MOLECULAR THERAPEUTICS · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called 4D-150 for adults with a specific eye condition known as macular neovascularization (MNV) that can occur due to age-related macular degeneration (AMD). The trial aims to see how effective this treatment is in improving vision and managing the symptoms of MNV. It is a Phase 3 trial, meaning it’s in the later stages of testing before the treatment can be considered for approval.

To participate in the trial, you must be at least 50 years old and have not received prior treatment for your MNV. Your eye condition should show signs of activity, which can be confirmed through specific eye tests. Additionally, your vision must be at a certain level for you to qualify. If eligible, participants can expect to be part of a study where they may receive either the new treatment or a standard treatment, while their vision and eye health will be closely monitored. It's important to know that individuals with certain other eye conditions or serious health issues may not be able to join this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥50 years of age at time of consent
• • Treatment naïve MNV secondary to nAMD in the study eye
• • 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
• 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