Clinical trial NCT06864988: 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Macular Neovascularization Secondary to Age-Related Macular Degeneration
Keywords: Age-related macular degeneration
AMD
Exudative AMD
Neovascular AMD
Exudative age-related macular degeneration
Neovascular age-related macular degeneration
Wet age-related macular degeneration
Wet macular degeneration
Wet AMD
wAMD
Retinal gene therapy
Intravitreal gene therapy
Genetic Medicine
Ocular Gene Therapy
nAMD
Lead sponsor: 4D Molecular Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

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

Primary outcomes:
measure: Mean change from baseline in BCVA ETDRS letter score at Week 52
timeFrame: 52 Weeks
Secondary outcomes:
measure: Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
timeFrame: 104 Weeks
measure: Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
timeFrame: 104 Weeks
measure: Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
timeFrame: 104 Weeks
measure: Mean change from baseline in CST over time through Weeks 52 and 104
timeFrame: 104 Weeks
measure: Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104
timeFrame: 104 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Scottsdale
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Springdale
country: United States
facility: Retina Partners of Northwest Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Huntington Beach
country: United States
facility: Retina Associates of Southern California
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Faculty Medical Clinics
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Orange
country: United States
facility: Gavin Herbert Eye Institute
state: California
city: Poway
country: United States
facility: Retina Consultants of San Diego
state: California
city: Riverside
country: United States
facility: Kaiser Permanente-Riverside Medical Center
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group Inc
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group Inc
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants - Santa Barbara
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Denver
country: United States
facility: RSC Research, LLC
state: Colorado
city: Danbury
country: United States
facility: Connecticut Eye Consultants
state: Connecticut
city: Hamden
country: United States
facility: New England Retina Associates (NERA)
state: Connecticut
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Gainesville
country: United States
facility: Vitreo Retinal Associates
state: Florida
city: Jacksonville
country: United States
facility: Florida Retina Institute - Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Sarasota
country: United States
facility: Retina Associates of Sarasota
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Elmhurst
country: United States
facility: Retina Associates - Elmhurst
state: Illinois
city: Lemont
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Wilmer Eye Institute John's Hopkins University
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants PC
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists - Hagerstown
state: Maryland
city: Waldorf
country: United States
facility: MD Medical Research
state: Maryland
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Madison
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: Southaven
country: United States
facility: Deep Blue Retina Clinical Research
state: Mississippi
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Teaneck
country: United States
facility: NJ Retina
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico Vision Research Center
state: New Mexico
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central New York
state: New York
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Wake Forest
country: United States
facility: North Carolina (NC) Retina Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cole Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Eugene
country: United States
facility: Verum Research, LLC
state: Oregon
city: Portland
country: United States
facility: EyeHealth Northwest Peterkort
state: Oregon
city: Bethlehem
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Scheie Eye Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Neuroscience Center
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research
state: Texas
city: Bellaire
country: United States
facility: Retina & Vitreous of Texas, PLLC
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Houston
country: United States
facility: Texas Retina Center
state: Texas
city: San Antonio
country: United States
facility: Retina Associates of South Texas PA
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas San Antonio
state: Texas
city: San Antonio
country: United States
facility: RCTX - Westover Hills Retina Center
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Fairfax
country: United States
facility: Retina Group of Washington
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Richmond
country: United States
facility: Retina Institute of Virginia
state: Virginia
city: Wausau
country: United States
facility: Eye Clinic of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: North York
country: Canada
facility: St. Michaels Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Retina Institute of Ottawa, Inc.
state: Ontario
city: Toronto
country: Canada
facility: Krembil Neuroscience Centre
state: Ontario
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center LLC
Study officials:
affiliation: 4D Molecular Therapeutics
name: Hersh Patel
role: STUDY_DIRECTOR
References: