Age-Related Macular Degeneration (ARMD) Clinical Trials

Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You

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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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• ≥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

Locations
United States
Arizona
Barnet Dulaney Perkins Eye Center
RECRUITING
Sun City
Maryland
Cumberland Valley Retina Consultants
RECRUITING
Hagerstown
Tennessee
Tennessee Retina, PC
RECRUITING
Nashville
Contact Information
Primary
4DMT Patient Advocacy
clinicaltrials@4DMT.com
(888) 748-8881
Time Frame
Start Date: 2025-07
Estimated Completion Date: 2029-02
Participants
Target number of participants: 400
Treatments
Experimental: 4D-150 IVT (3E10 vg/eye)
Active_comparator: Aflibercept (AFLB) 2 mg IVT
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: 4D Molecular Therapeutics

This content was sourced from clinicaltrials.gov

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