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 (43) 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
Retina Associates
RECRUITING
Tucson
California
Retinal Diagnostic Center
RECRUITING
Campbell
Retina Consultants of Orange County
RECRUITING
Fullerton
West Coast Retina Medical Group
RECRUITING
San Francisco
Colorado
Southwest Retina Consultants
RECRUITING
Durango
Florida
ClearVista Clinical Research
RECRUITING
Hudson
Retina Vitreous Associates of Florida
RECRUITING
Tampa
Georgia
Thomas Eye Group
RECRUITING
Sandy Springs
Maryland
The Retina Care Center
RECRUITING
Baltimore
Cumberland Valley Retina Consultants
RECRUITING
Hagerstown
Mid Atlantic Retina Specialist
RECRUITING
Hagerstown
North Carolina
North Carolina Retina Associates
RECRUITING
Cary
New York
New York Presbyterian Hospital - Columbia University Medical Center
NOT_YET_RECRUITING
New York
Vitreoretinal Consultants of NY
RECRUITING
Westbury
Ohio
Cincinnati Eye Institute
RECRUITING
Cincinnati
Oregon
Verum Research, LLC
RECRUITING
Eugene
South Carolina
Charleston Neuroscience Institute, LLC
RECRUITING
Bluffton
Carolina Eyecare
RECRUITING
Mt. Pleasant
Tennessee
Tennessee Retina, PC
RECRUITING
Nashville
Texas
Southwest Retina Specialist - Panhandle Eye group, LLP
RECRUITING
Amarillo
Texas Retina Associate
RECRUITING
Dallas
Tyler Retina Consultants
RECRUITING
Tyler
Utah
Rocky Mountain Retina Consultants
RECRUITING
Salt Lake City
Washington
Pacific Northwest Retina
RECRUITING
Silverdale
Other Locations
Argentina
Charles Research Center
RECRUITING
Buenos Aires
Bulgaria
Zora Eye Hospital
RECRUITING
Sofia
Germany
Internationale Innovative Ophthalmochirurgie GbR
RECRUITING
Düsseldorf
Hungary
Budapest Retina Associates
RECRUITING
Budapest
Semmelweis Egyetem - Szemészeti Klinika
RECRUITING
Budapest
DE KK Ophthalmology Clinic
RECRUITING
Debrecen
Ganglion Medical Center
RECRUITING
Pécs
SzTE SZAKK Szemeszeti Klinika
RECRUITING
Szeged
Japan
Hayashi Eye Hospital
RECRUITING
Fukuoka
Latvia
P.Stradins University Hospital
RECRUITING
Riga
Riga East University hospital
RECRUITING
Riga
Lithuania
Vilnius University Hospital Santaros Klinikos
RECRUITING
Vilnius
Portugal
Aibili - Cec
RECRUITING
Coimbra
Singapore
Singapore Eye Research Institute (SERI)
RECRUITING
Singapore
Tan Tock Seng Hospital TTSH
RECRUITING
Singapore
Spain
Clinica Bonanova de Cirugía Ocular
RECRUITING
Barcelona
Hospital Universitario Virgen Macarena
RECRUITING
Seville
United Kingdom
The Retina Clinic London
RECRUITING
London
Contact Information
Primary
4DMT Patient Advocacy
clinicaltrials@4DMT.com
(888) 748-8881
Time Frame
Start Date: 2025-07-22
Estimated Completion Date: 2029-02
Participants
Target number of participants: 480
Treatments
Experimental: 4D-150 IVT (3E10 vg/eye)
Active_comparator: Aflibercept (AFLB) 2 mg IVT
Sponsors
Leads: 4D Molecular Therapeutics

This content was sourced from clinicaltrials.gov