Treatment for macular neovascularization caused by age-related macular degeneration
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
This study is testing a new treatment called 4D-150 to see if it can help adults with vision problems caused by age-related macular degeneration, compared to a standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | 4D Molecular Therapeutics Industry-sponsored |
| Locations | 95 sites (Phoenix, Arizona and 94 other locations) |
| Trial ID | NCT06864988 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial evaluates the efficacy of 4D-150, an investigational treatment, in adults suffering from macular neovascularization secondary to age-related macular degeneration (AMD). Participants will be randomly assigned to receive either 4D-150 or EYLEA®, an established treatment, to compare their effects on the condition. The study focuses on treatment-naïve patients with active macular neovascularization, utilizing advanced imaging techniques to confirm eligibility and monitor treatment response. The trial aims to provide insights into the potential benefits of 4D-150 in improving visual outcomes for patients with this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 and older with treatment-naïve macular neovascularization secondary to AMD.
Not a fit: Patients with macular neovascularization from causes other than AMD or those with certain ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with macular neovascularization due to AMD.
How similar studies have performed: Previous studies have shown promising results with similar approaches in treating macular neovascularization, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 94 other locations
- Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States (Not_yet_recruiting)
- Retinal Research Institute, LLC — Scottsdale, Arizona, United States (Recruiting)
- Retina Partners of Northwest Arkansas — Springdale, Arkansas, United States (Recruiting)
- California Retina Consultants — Bakersfield, California, United States (Recruiting)
- Retina Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
- The Retina Partners — Encino, California, United States (Recruiting)
- Retina Associates of Southern California — Huntington Beach, California, United States (Not_yet_recruiting)
- Loma Linda University Faculty Medical Clinics — Loma Linda, California, United States (Not_yet_recruiting)
- Jules Stein Eye Institute — Los Angeles, California, United States (Not_yet_recruiting)
- Northern California Retina Vitreous Associates — Mountain View, California, United States (Not_yet_recruiting)
- Gavin Herbert Eye Institute — Orange, California, United States (Not_yet_recruiting)
- Retina Consultants of San Diego — Poway, California, United States (Not_yet_recruiting)
- Kaiser Permanente-Riverside Medical Center — Riverside, California, United States (Not_yet_recruiting)
- Retinal Consultants Medical Group Inc — Sacramento, California, United States (Recruiting)
- Retinal Consultants Medical Group Inc — Sacramento, California, United States (Recruiting)
- Orange County Retina Medical Group — Santa Ana, California, United States (Not_yet_recruiting)
- California Retina Consultants - Santa Barbara — Santa Barbara, California, United States (Recruiting)
- Bay Area Retina Associates — Walnut Creek, California, United States (Recruiting)
- University of Colorado, Denver — Aurora, Colorado, United States (Not_yet_recruiting)
- RSC Research, LLC — Denver, Colorado, United States (Recruiting)
- Connecticut Eye Consultants — Danbury, Connecticut, United States (Not_yet_recruiting)
- New England Retina Associates (NERA) — Hamden, Connecticut, United States (Not_yet_recruiting)
- Rand Eye Institute — Deerfield Beach, Florida, United States (Recruiting)
- Retina Group of Florida — Fort Lauderdale, Florida, United States (Recruiting)
- Vitreo Retinal Associates — Gainesville, Florida, United States (Recruiting)
- Florida Retina Institute - Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Florida Retina Consultants — Lakeland, Florida, United States (Recruiting)
- Florida Retina Institute — Orlando, Florida, United States (Recruiting)
- Retina Specialty Institute — Pensacola, Florida, United States (Recruiting)
- Retina Vitreous Associates of Florida — Saint Petersburg, Florida, United States (Recruiting)
- Retina Associates of Sarasota — Sarasota, Florida, United States (Recruiting)
- East Florida Eye Institute — Stuart, Florida, United States (Not_yet_recruiting)
- Southeast Retina Center — Augusta, Georgia, United States (Recruiting)
- Georgia Retina PC — Marietta, Georgia, United States (Not_yet_recruiting)
- Retina Consultants of Hawaii — 'Aiea, Hawaii, United States (Not_yet_recruiting)
- University of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
- Retina Associates - Elmhurst — Elmhurst, Illinois, United States (Recruiting)
- University Retina and Macula Associates, PC — Lemont, Illinois, United States (Recruiting)
- Midwest Eye Institute — Carmel, Indiana, United States (Recruiting)
- Retina Associates of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Wilmer Eye Institute John's Hopkins University — Baltimore, Maryland, United States (Not_yet_recruiting)
- Retina Group of Washington — Chevy Chase, Maryland, United States (Not_yet_recruiting)
- Cumberland Valley Retina Consultants PC — Hagerstown, Maryland, United States (Recruiting)
- Mid Atlantic Retina Specialists - Hagerstown — Hagerstown, Maryland, United States (Recruiting)
- MD Medical Research — Waldorf, Maryland, United States (Not_yet_recruiting)
- New England Retina Consultants — Springfield, Massachusetts, United States (Not_yet_recruiting)
- Mississippi Retina Associates — Madison, Mississippi, United States (Recruiting)
- Deep Blue Retina Clinical Research — Southaven, Mississippi, United States (Recruiting)
- The Retina Institute — Saint Louis, Missouri, United States (Recruiting)
- Sierra Eye Associates — Reno, Nevada, United States (Recruiting)
+45 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: 4DMT Patient Advocacy
- Email: clinicaltrials@4DMT.com
- Phone: (888) 748-8881
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.