Actively Recruiting
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
Led by 4D Molecular Therapeutics · Updated on 2026-04-16
480
Participants Needed
94
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a single intravitreal injection of 4D-150 in adults aged 50 and older with macular neovascularization caused by neovascular age-related macular degeneration (nAMD). This Phase 3 trial compares 4D-150 to an active control treatment, aflibercept, to better understand how these treatments affect vision and eye health in this condition. Participants are randomly assigned to receive either one dose of 4D-150 or aflibercept injections at scheduled visits. The 4D-150 is given as a single intravitreal injection on Day 1, while aflibercept is administered during follow-up visits as needed. The study includes a 52-week period to assess visual changes and a longer 104-week period to monitor the need for additional aflibercept injections and other eye health measures. During the study, participants will undergo eye exams including measurements of visual acuity using the ETDRS letter score and evaluations of the central subfield thickness in the retina. Researchers will track the number and timing of aflibercept injections and monitor any anatomical or functional changes in the treated eye. Safety and stability of vision will be observed throughout the trial period, which lasts up to two years.
CONDITIONS
Brief Title
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 50 years of age or older at the time of consent
- Macular neovascularization secondary to neovascular age-related macular degeneration with intravitreal anti-VEGF treatment history in the study eye, either treatment-na�ve or previously treated with up to 4 injections
- Diagnosis of neovascular age-related macular degeneration no more than 6 months prior to screening if previously treated
- Documented anatomical improvement and visual stability or improvement from prior anti-VEGF treatment as determined by the Investigator
- Active subfoveal or juxtafoveal/extrafoveal macular neovascularization with subfoveal component confirmed by fluorescein angiography or spectral domain optical coherence tomography at screening
- Demonstrated clinical response to aflibercept and functional stability in the study eye confirmed by Reading Center
- Best Corrected Visual Acuity between 25 and 78 ETDRS letters (20/320 to 20/32 Snellen equivalent) in the study eye at screening
- Central Subfield Thickness less than or equal to 500 microns in the study eye at screening confirmed by Reading Center
You will not qualify if you...
- Macular neovascularization due to causes other than neovascular age-related macular degeneration 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
- Any prior or concurrent treatment for macular neovascularization or vitreomacular-interface abnormalities other than allowed prior intravitreal anti-VEGF in the study eye
- Major illness or major surgery within 28 days before screening
- Uncontrolled blood pressure
- Acute coronary syndrome, myocardial infarction, coronary artery revascularization, cerebrovascular accident, or transient ischemic attack within 6 months before screening
- History of autoimmune condition that may increase risk of uveitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive a single intravitreal injection of either 4D-150 or aflibercept on Day 1 and are monitored for treatment response.
Multiple visits for assessments and possible aflibercept injections after Week 4 through Week 52
Duration - Up to 52 weeks
Participants are followed for additional safety and efficacy monitoring after treatment through Week 104.
Multiple visits for long-term monitoring through Week 104
Trial Site Locations
Total: 94 locations
1
Research Network Arizona
Scottsdale, Arizona, United States, 85255
Actively Recruiting
2
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, United States, 85351
Actively Recruiting
3
Retina Associates
Tucson, Arizona, United States, 85704
Actively Recruiting
4
Retinal Diagnostic Center
Campbell, California, United States, 95008
Actively Recruiting
5
Retina Consultants of Orange County
Fullerton, California, United States, 92835
Actively Recruiting
6
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Actively Recruiting
7
Retinal Consultants Medical Group Inc.
Sacramento, California, United States, 95825
Actively Recruiting
8
Retinal Consultants Medical Group
Sacramento, California, United States, 95841
Actively Recruiting
9
West Coast Retina Medical Group
San Francisco, California, United States, 94109
Actively Recruiting
10
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
Actively Recruiting
11
Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
12
Southwest Retina Consultants
Durango, Colorado, United States, 81303
Actively Recruiting
13
ClearVista Clinical Research
Hudson, Florida, United States, 34667
Actively Recruiting
14
Florida Retina Institute
Orlando, Florida, United States, 32806
Actively Recruiting
15
Retina Specialty Institute
Pensacola, Florida, United States, 32503
Actively Recruiting
16
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711
Actively Recruiting
17
East Florida Eye Institute
Stuart, Florida, United States, 34994
Actively Recruiting
18
Retina Vitreous Associates of Florida
Tampa, Florida, United States, 33617
Actively Recruiting
19
Thomas Eye Group
Sandy Springs, Georgia, United States, 30328
Actively Recruiting
20
Retina Associates, Ltd.
Elmhurst, Illinois, United States, 60126
Actively Recruiting
21
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States, 60452
Actively Recruiting
22
Illinois Retina Associates
Oak Park, Illinois, United States, 60304
Actively Recruiting
23
Springfield Clinic
Springfield, Illinois, United States, 62703
Actively Recruiting
24
Retina Partners Midwest, PC
Carmel, Indiana, United States, 46032
Actively Recruiting
25
The Retina Care Center
Baltimore, Maryland, United States, 21209
Actively Recruiting
26
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
Actively Recruiting
27
Mid Atlantic Retina Specialist
Hagerstown, Maryland, United States, 21740
Actively Recruiting
28
New England Retina Consultants
Springfield, Massachusetts, United States, 01107
Actively Recruiting
29
Foundation for Vision Research
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
30
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
31
Envision Ocular, LLC
Bloomfield, New Jersey, United States, 07003
Actively Recruiting
32
Retina Vitreous Surgeons of CNY PC
Liverpool, New York, United States, 13088
Actively Recruiting
33
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
34
Vitreoretinal Consultants of NY
Westbury, New York, United States, 11590
Actively Recruiting
35
North Carolina Retina Associates
Cary, North Carolina, United States, 27511
Actively Recruiting
36
North Carolina Retina Associates
Wake Forest, North Carolina, United States, 27587
Actively Recruiting
37
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Actively Recruiting
38
Verum Research, LLC
Eugene, Oregon, United States, 947401
Actively Recruiting
39
EyeHealth Northwest
Portland, Oregon, United States, 97233
Actively Recruiting
40
Erie Retina Research
Erie, Pennsylvania, United States, 16505
Actively Recruiting
41
Charleston Neuroscience Institute, LLC
Bluffton, South Carolina, United States, 29910
Actively Recruiting
42
Carolina Eyecare
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
43
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
Actively Recruiting
44
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
Actively Recruiting
45
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
Actively Recruiting
46
Southwest Retina Specialist - Panhandle Eye group, LLP
Amarillo, Texas, United States, 79106
Actively Recruiting
47
Austin Clinical Research
Austin, Texas, United States, 78750
Actively Recruiting
48
Texas Retina Associate
Dallas, Texas, United States, 75231
Actively Recruiting
49
Tyler Retina Consultants
Tyler, Texas, United States, 75703
Actively Recruiting
50
Strategic Clinical Research
Willow Park, Texas, United States, 76087
Actively Recruiting
51
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States, 84107
Actively Recruiting
52
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502
Actively Recruiting
53
Pacific Northwest Retina
Silverdale, Washington, United States, 98383
Actively Recruiting
54
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States, 54403
Actively Recruiting
55
Grupo Láser Visión
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
56
Microcirugia Ocular Rosario
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
57
Centro Privado de Ojos
Buenos Aires, Argentina, 1033
Actively Recruiting
58
Charles Research Center
Buenos Aires, Argentina, 1116
Actively Recruiting
59
OFTALMOS
Buenos Aires, Argentina, 1830
Actively Recruiting
60
Centrovisión
Mendoza, Argentina, 5500
Actively Recruiting
61
Adelaide Eye and Retina Centre
Adelaide, Australia, SA 5000
Actively Recruiting
62
Eye Clinic Albury Wodonga
Albury, Australia, NSW 2640
Actively Recruiting
63
Strathfield Retina Clinic
Strathfield, Australia, NSW 2135
Actively Recruiting
64
Sydney Retina Clinic and Day Surgery
Sydney, Australia, NSW 2000
Actively Recruiting
65
Zora Eye Hospital
Sofia, Bulgaria
Actively Recruiting
66
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf, Germany
Actively Recruiting
67
Augenzentrum Frankfurt
Frankfurt, Germany, 60549
Actively Recruiting
68
Dietrich Bonhoeffer Klinikum
Neubrandenburg, Germany, 17036
Actively Recruiting
69
Bajcsy-Zsilinszky Kórház
Budapest, Hungary, 1106
Actively Recruiting
70
Budapest Retina Associates
Budapest, Hungary
Actively Recruiting
71
Semmelweis Egyetem - Szemészeti Klinika
Budapest, Hungary
Actively Recruiting
72
DE KK Ophthalmology Clinic
Debrecen, Hungary
Actively Recruiting
73
Ganglion Medical Center
Pécs, Hungary
Actively Recruiting
74
SzTE SZAKK Szemeszeti Klinika
Szeged, Hungary
Actively Recruiting
75
AOU delle Marche
Ancona, Italy, 60126
Actively Recruiting
76
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, Japan, 310-0845
Actively Recruiting
77
University of the Ryukyus Hospital
Ginowan, Okinawa, Japan, 901-2725
Actively Recruiting
78
Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital
Fukuoka, Japan, 811-0213
Actively Recruiting
79
Hayashi Eye Hospital
Fukuoka, Japan
Actively Recruiting
80
National Hospital Organization Tokyo Medical Center
Tokyo, Japan, 152-8902
Actively Recruiting
81
P.Stradins University Hospital
Riga, Latvia
Actively Recruiting
82
Riga East University hospital
Riga, Latvia
Actively Recruiting
83
Ziemekurzemes Regionala Slimnica
Ventspils, Latvia
Actively Recruiting
84
Hospital of Lithuanian University of Health Sciences
Kaunas, Lithuania, LT-50161
Actively Recruiting
85
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
86
Aibili - Cec
Coimbra, Portugal
Actively Recruiting
87
Singapore Eye Research Institute (SERI)
Singapore, Singapore
Actively Recruiting
88
Tan Tock Seng Hospital TTSH
Singapore, Singapore
Actively Recruiting
89
Miranza Instituto Gomez-Ulla
Santiago de Compostela, Spain, Spain, 15706
Actively Recruiting
90
Clinica Bonanova de Cirugía Ocular
Barcelona, Spain
Actively Recruiting
91
Hospital Universitario Virgen Macarena
Seville, Spain
Actively Recruiting
92
Bradford Royal Infirmary
Bradford, UK, United Kingdom, BD9 6TB
Actively Recruiting
93
The Retina Clinic London
London, United Kingdom
Actively Recruiting
94
Sunderland Eye Infirmary
Sunderland, United Kingdom, SR2 9HP
Actively Recruiting
Research Team
4
4DMT Patient Advocacy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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