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

RecruitingPhase 3

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

Who can join

Ages 50 and older · All sexes

Full 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

About the study

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

What is being tested

Sponsor: 4D Molecular Therapeutics · Participants: 480 · Started: Jul 22, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07064759

Locations in the U.S.

ArizonaResearch Network Arizona, Scottsdale
Barnet Dulaney Perkins Eye Center, Sun City
Retina Associates, Tucson
CaliforniaRetinal Diagnostic Center, Campbell
Retina Consultants of Orange County, Fullerton
Northern California Retina Vitreous Associates, Mountain View
Retinal Consultants Medical Group, Sacramento
Retinal Consultants Medical Group Inc., Sacramento
West Coast Retina Medical Group, San Francisco
Bay Area Retina Associates, Walnut Creek
ColoradoRetina Consultants of Southern Colorado P.C., Colorado Springs
Southwest Retina Consultants, Durango
FloridaClearVista Clinical Research, Hudson
Florida Retina Institute, Orlando
Retina Specialty Institute, Pensacola
Retina Vitreous Associates of Florida, St. Petersburg
East Florida Eye Institute, Stuart
Retina Vitreous Associates of Florida, Tampa
GeorgiaThomas Eye Group, Sandy Springs
IllinoisRetina Associates, Ltd., Elmhurst
University Retina and Macula Associates, PC, Oak Forest
Illinois Retina Associates, Oak Park
Springfield Clinic, Springfield
IndianaRetina Partners Midwest, PC, Carmel
MarylandThe Retina Care Center, Baltimore
Cumberland Valley Retina Consultants, Hagerstown
Mid Atlantic Retina Specialist, Hagerstown
MassachusettsNew England Retina Consultants, Springfield
MichiganFoundation for Vision Research, Grand Rapids
NevadaSierra Eye Associates, Reno
New JerseyEnvision Ocular, LLC, Bloomfield
New YorkRetina Vitreous Surgeons of CNY PC, Liverpool
New York Presbyterian Hospital - Columbia University Medical Center, New York
Vitreoretinal Consultants of NY, Westbury
North CarolinaNorth Carolina Retina Associates, Cary
North Carolina Retina Associates, Wake Forest
OhioCincinnati Eye Institute, Cincinnati
OregonVerum Research, LLC, Eugene
EyeHealth Northwest, Portland
PennsylvaniaErie Retina Research, Erie
South CarolinaCharleston Neuroscience Institute, LLC, Bluffton
Carolina Eyecare, Mt. Pleasant
Palmetto Retina Center, West Columbia
South DakotaBlack Hills Regional Eye Institute, Rapid City
TennesseeTennessee Retina, PC, Nashville
TexasSouthwest Retina Specialist - Panhandle Eye group, LLP, Amarillo
Austin Clinical Research, Austin
Texas Retina Associate, Dallas
Tyler Retina Consultants, Tyler
Strategic Clinical Research, Willow Park
UtahRocky Mountain Retina Consultants, Salt Lake City
VirginiaPiedmont Eye Center, Lynchburg
WashingtonPacific Northwest Retina, Silverdale
WisconsinEye Clinic of Wisconsin, Wausau

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.