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Purpose

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

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
4D-150 IVT (3E10 vg/eye)
  • Biological: 4D-150 IVT (3E10 vg/eye)
    If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1
Active Comparator
Aflibercept (AFLB) 2 mg IVT
  • Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)
    Eylea (aflibercept) will be administered at applicable visits

Recruiting Locations

Barnet Dulaney Perkins Eye Center
Phoenix 5308655, Arizona 5551752 85016

Retinal Research Institute, LLC
Scottsdale 5313457, Arizona 5551752 85254

Retina Partners of Northwest Arkansas
Springdale 4132093, Arkansas 4099753 72764

California Retina Consultants
Bakersfield 5325738, California 5332921 93309

Retina Vitreous Associates Medical Group
Beverly Hills 5328041, California 5332921 90211

The Retina Partners
Encino 5346649, California 5332921 91436

Retina Associates of Southern California
Huntington Beach 5358705, California 5332921 92647

Loma Linda University Faculty Medical Clinics
Loma Linda 5367696, California 5332921 92354

Jules Stein Eye Institute
Los Angeles 5368361, California 5332921 90095

Northern California Retina Vitreous Associates
Mountain View 5375480, California 5332921 94040

Retina Consultants of San Diego
Poway 5384690, California 5332921 92064

Kaiser Permanente-Riverside Medical Center
Riverside 5387877, California 5332921 92505

Retinal Consultants Medical Group Inc
Sacramento 5389489, California 5332921 95825

Retinal Consultants Medical Group Inc
Sacramento 5389489, California 5332921 95840

Orange County Retina Medical Group
Santa Ana 5392900, California 5332921 92705

California Retina Consultants - Santa Barbara
Santa Barbara 5392952, California 5332921 93103

Bay Area Retina Associates
Walnut Creek 5406990, California 5332921 94598

University of Colorado, Denver
Aurora 5412347, Colorado 5417618 80045

Retina Consultants of Southern Colorado
Colorado Springs 5417598, Colorado 5417618 80909

RSC Research, LLC
Denver 5419384, Colorado 5417618 80210

Connecticut Eye Consultants
Danbury 4832353, Connecticut 4831725 06810

Rand Eye Institute
Deerfield Beach 4153071, Florida 4155751 33064

Retina Group of Florida
Fort Lauderdale 4155966, Florida 4155751 33308

Vitreo Retinal Associates
Gainesville 4156404, Florida 4155751 34481

Florida Retina Institute - Jacksonville
Jacksonville 4160021, Florida 4155751 32216

Florida Retina Consultants
Lakeland 4161438, Florida 4155751 33805

Florida Retina Institute
Orlando 4167147, Florida 4155751 32806

Retina Specialty Institute
Pensacola 4168228, Florida 4155751 32503

Retina Associates of Sarasota
Sarasota 4172131, Florida 4155751 34232

Retina Vitreous Associates of Florida
St. Petersburg 4171563, Florida 4155751 33711

East Florida Eye Institute
Stuart 4174201, Florida 4155751 34994

Southeast Retina Center
Augusta 4180531, Georgia 4197000 30909

Georgia Retina PC
Marietta 4207783, Georgia 4197000 30060

Retina Consultants of Hawaii
‘Aiea 5856430, Hawaii 5855797 96701

University of Chicago
Chicago 4887398, Illinois 4896861 60637

Retina Associates - Elmhurst
Elmhurst 4891010, Illinois 4896861 60126

University Retina and Macula Associates, PC
Lemont 4899581, Illinois 4896861 60439

Illinois Retina Associates
Oak Park 4904381, Illinois 4896861 60304

Springfield Clinic
Springfield 4250542, Illinois 4896861 62703

Midwest Eye Institute
Carmel 4255466, Indiana 4921868 46290

Maine Eye Center
Portland 4975802, Maine 4971068 04101

Wilmer Eye Institute John's Hopkins University
Baltimore 4347778, Maryland 4361885 21287

Retina Group of Washington
Chevy Chase 4351335, Maryland 4361885 20815

Cumberland Valley Retina Consultants PC
Hagerstown 4357141, Maryland 4361885 21740

Mid Atlantic Retina Specialists - Hagerstown
Hagerstown 4357141, Maryland 4361885 21740

MD Medical Research
Waldorf 4372599, Maryland 4361885 20745

New England Retina Consultants
Springfield 4951788, Massachusetts 6254926 01107

Mississippi Retina Associates
Madison 4434663, Mississippi 4436296 39110

Deep Blue Retina Clinical Research
Southaven 4446675, Mississippi 4436296 38671

The Retina Institute
St Louis 4407066, Missouri 4398678 63128

Sierra Eye Associates
Reno 5511077, Nevada 5509151 89502

Envision Ocular, LLC
Bloomfield 5095779, New Jersey 5101760 07003

NJ Retina
Edison 5097529, New Jersey 5101760 08820

NJ Retina
Teaneck 5105262, New Jersey 5101760 07666

Eye Associates of New Mexico Vision Research Center
Albuquerque 5454711, New Mexico 5481136 87109

Retina-Vitreous Surgeons of Central New York
Liverpool 5124925, New York 5128638 13088

Vitreous Retina Macula Consultants of New York
New York 5128581, New York 5128638 10022

Retina Associates of Western New York
Rochester 5134086, New York 5128638 14620

Western Carolina Retinal Associate PA
Asheville 4453066, North Carolina 4482348 28803

Duke Eye Center
Durham 4464368, North Carolina 4482348 27705

North Carolina (NC) Retina Associates
Wake Forest 4497290, North Carolina 4482348 27587

Atrium Health Wake Forest Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157

Piedmont Retina Specialists - Winston Salem Office
Winston-Salem 4499612, North Carolina 4482348 27157

Retina Associates of Cleveland
Cleveland 5150529, Ohio 5165418 44122

Retina Associates of Cleveland
Cleveland 5150529, Ohio 5165418 44130

Cole Eye Institute
Cleveland 5150529, Ohio 5165418 44195

Retina Vitreous Center
Edmond 4535740, Oklahoma 4544379 73013

Verum Research, LLC
Eugene 5725846, Oregon 5744337 97401

EyeHealth Northwest Peterkort
Portland 5746545, Oregon 5744337 97225

Mid Atlantic Retina
Bethlehem 5180225, Pennsylvania 6254927 18017

Erie Retina Research
Erie 5188843, Pennsylvania 6254927 16507

The Scheie Eye Institute
Philadelphia 4560349, Pennsylvania 6254927 19104

Charleston Neuroscience Center
Charleston 4574324, South Carolina 4597040 29414

Charleston Neuroscience Institute
Ladson 4584277, South Carolina 4597040 29456

Palmetto Retina Center
West Columbia 4600541, South Carolina 4597040 29169

Black Hills Regional Eye Institute
Rapid City 5768233, South Dakota 5769223 57701

Retina Research Institute of Texas
Abilene 4669635, Texas 4736286 79606

Texas Retina Associates
Arlington 4671240, Texas 4736286 76012

Austin Research Center for Retina
Austin 4671654, Texas 4736286 78705

Austin Retina Associates
Austin 4671654, Texas 4736286 78705

Austin Clinical Research
Austin 4671654, Texas 4736286 78750

Retina & Vitreous of Texas, PLLC
Bellaire 4673353, Texas 4736286 77401

Retina Consultants of Houston
Bellaire 4673353, Texas 4736286 77401

Texas Retina Center
Houston 4699066, Texas 4736286 77043

Retina Associates of South Texas PA
San Antonio 4726206, Texas 4736286 78240

Retina Consultants of Texas San Antonio
San Antonio 4726206, Texas 4736286 78240

RCTX - Westover Hills Retina Center
San Antonio 4726206, Texas 4736286 78251

Retina Consultants of Texas
The Woodlands 4736476, Texas 4736286 77384

Strategic Clinical Research Group, LLC
Willow Park 4742296, Texas 4736286 76087

Retina Group of Washington
Fairfax 4758023, Virginia 6254928 22031

Piedmont Eye Center
Lynchburg 4771075, Virginia 6254928 24502

Retina Institute of Virginia
Richmond 4781708, Virginia 6254928 23235

Eye Clinic of Wisconsin
Wausau 5278120, Wisconsin 5279468 54403

More Details

NCT ID
NCT06864988
Status
Recruiting
Sponsor
4D Molecular Therapeutics

Study Contact

4DMT Patient Advocacy
(888) 748-8881
clinicaltrials@4DMT.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center