Treatment for wet age-related macular degeneration using 4D-150
Official title: A Phase 1/2 Dose-Escalation and Randomized, Controlled, Masked Expansion Trial of Intravitreal 4D-150 Gene Therapy in Adults With Neovascular (Wet) Age-Related Macular Degeneration
Run by 4D Molecular Therapeutics · NCT05197270 · Data updated 2026-11-12
This study is testing a new gene therapy called 4D-150 to see if it can improve vision in adults with wet age-related macular degeneration who are already receiving other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 215 (estimated) |
| Sponsor | 4D Molecular Therapeutics Industry-sponsored |
| Drugs / interventions | ranibizumab, faricimab, bevacizumab |
| Locations | 26 sites (Phoenix, Arizona and 25 other locations) |
| Status | Recruiting |
| Started | December 9, 2021 |
| Main results expected | March 2027 |
| Study ends | January 2031 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT05197270 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 50 and older diagnosed with macular choroidal neovascularization secondary to AMD who are currently responding to anti-VEGF treatment.
✕Probably not a fit
Patients with conditions that prevent visual acuity improvement or those who have had prior treatments that interfere with the study eye may not benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1/2 trial evaluates the safety and efficacy of 4D-150, a gene therapy administered via intravitreal injection, in adults with neovascular age-related macular degeneration (AMD) who are currently receiving anti-VEGF treatment. The study includes a dose-escalation phase followed by a randomized, controlled expansion phase, with participants monitored for 24 months after treatment. Long-term follow-up will assess the safety and clinical activity of the therapy over five years. The trial aims to determine the potential benefits of 4D-150 in improving vision outcomes for patients with wet AMD.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients suffering from wet age-related macular degeneration.
How similar studies have gone: While gene therapy approaches for AMD are being explored, this specific intervention is novel and has not been widely tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
* 50 years of age Individuals eligible to participate in the trial must meet the following inclusion criteria: 1. ≥50 years of age 2. Diagnosed with CNV secondary to AMD (confirmed by reading center) 3. BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye, and BCVA in the study eye: 4. Central subfield thickness (CST) and/or presence of subretinal or intraretinal fluid requiring continued anti-VEGF therapy in the study eye, as assessed by SD-OCT; and confirmed by a reading center): 5. Study eye amenable to IVT injection 6. Ability to perform tests of visual and retinal function and structure, and ability to comply with other protocol-specified procedures 7. Currently receiving anti-VEGF treatment (e.g. ranibizumab, aflibercept, faricimab or bevacizumab) in the study eye AND has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening: Note: Day -7 aflibercept will be administered ≥ 4 weeks from last IVT anti-VEGF 8. Subjects receiving 4D-150 agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Medical records available to document history of anti-VEGF therapy (dates, drugs, and dosage) for a minimum of 12 months prior to Screening 10. Provide written informed consent. Contralateral Eye Sub-study-Specific Criteria: 1. Received 4D-150 in study eye-1 at least 6 months prior to Contralateral Substudy Screening Visit NOTE: Subjects who received 4D-150 in study eye-1 as part of the Shedding Substudy are also eligible to participate in the Contralateral Eye Substudy only after biological samples from all matrices were at or below the limit of quantitation for vector genomes in at least 3 consecutive measurements AND at least 6 months has passed since 4D-150 administration to study eye-1. 2. Macular neovascularization (MNV) secondary to AMD in study eye-2 as assessed on historical images at any time by SD-OCT (required) and FA when available or fundus photography when available or at screening based on SD-OCT, FA and fundus photography (confirmed by the reading center) 3. History of at least 1 anti-VEGF injection in study eye-2 within 6 months prior to Screening (last anti-VEGF injection must be at least 28 days prior to Day 7) AND has demonstrated a clinical response consistent with anti-VEGF activity by historical OCT at any time point prior to screening with confirmed response by the reading center (Screening OCT can be confirmatory) 4. BCVA between 25 and 83 ETDRS letters, inclusive (20/320 20/25 Snellen) in study eye-2 5. Study eye-2 amenable to IVT injection 6. BCVA ≥34 ETDRS letters (\~20/200) in the previously treated study eye-1 7. Ability to comply with protocol-specified procedures and visits, in the Investigator's judgment 8. Agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to study eye-2 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Provide written informed consent. Shedding Substudy-specific Inclusion Criteria: 1. ≥50 years of age 2. Diagnosed with MNV secondary to AMD as assessed on historical images at any time by spectral domain optical coherence tomography (SD-OCT) (required) and fluorescein angiography when available or fundus photography when available or at screening based on SD-OCT, FA and fundus photography (confirmed by Reading Center) 3. Best corrected visual acuity (BCVA) between 10 and 83 ETDRS letters, inclusive (\~20/640 and 20/25, respectively) in the study eye at Screening 4. BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye 5. Currently receiving anti-VEGF treatment (e.g. ranibizumab, aflibercept, faricimab or bevacizumab) in the study eye; minimum of 1 injection within the last 6 months (last anti-VEGF injection must be at least 28 days prior to Day 7) AND has demonstrated a clinical response consistent with anti-VEGF activity by historical OCT at any time prior to screening with confirmed response by the reading center (Screening OCT can be confirmatory) 6. Study eye amenable to IVT injection 7. Ability to perform tests of visual and retinal function and structure, and ability to comply with other protocol-specified procedures, in the Investigator's judgment 8. Agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Provide written informed consent.
Where it's running
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Barnet Delaney Perkins Eye Center
Phoenix, Arizona, United States Recruiting -
California Retina Consultants
Oxnard, California, United States Recruiting -
Retinal Consultants Medical Group
Sacramento, California, United States Recruiting -
Colorado Retina Associates
Lakewood, Colorado, United States Recruiting -
Retina Group of Florida
Fort Lauderdale, Florida, United States Recruiting -
Vitreo Retinal Associates
Gainesville, Florida, United States Recruiting
Show 20 more locations
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Florida Eye Associates
Melbourne, Florida, United States Recruiting -
Retinal Specialty Institute
Pensacola, Florida, United States Recruiting -
Retina Vitreous Associates of Florida
Tampa, Florida, United States Recruiting -
University Retina and Macula Associates
Oak Forest, Illinois, United States Recruiting -
Retina Partners Midwest
Carmel, Indiana, United States Recruiting -
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States Recruiting -
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center
Boston, Massachusetts, United States Recruiting -
Sierra Eye Associates
Reno, Nevada, United States Recruiting -
Verum Research, LLC
Eugene, Oregon, United States Recruiting -
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States Recruiting -
Palmetto Retina Center, LLC
West Columbia, South Carolina, United States Recruiting -
Tennessee Retina
Nashville, Tennessee, United States Recruiting -
Austin Clinical Research
Austin, Texas, United States Recruiting -
Valley Retina Institute, PA
McAllen, Texas, United States Recruiting -
Emanuelli Research and Development Center, LLC
Arecibo, Puerto Rico Recruiting -
Rand Eye Institute
Deerfield Beach, Florida, United States Suspended -
Retina Vitreous Consultants, LLP DBA Retina Group of Florida
Fort Lauderdale, Florida, United States Active not recruiting -
Western Carolina Retinal Associates
Asheville, North Carolina, United States Withdrawn -
Retina Consultants of Texas
The Woodlands, Texas, United States Withdrawn -
Pacific Northwest Retina LLC
Bellevue, Washington, United States Withdrawn
Study contacts
- Study coordinator: 4DMT Patient Advocacy
- Email: clinicaltrials@4DMT.com
- Phone: (888) 748-8881
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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EYC-0305 in Neovascular (Wet) AMD: First-in-Patients Safety and Tolerability Study
This study tests whether EYC-0305 given as an eye injection every 24 weeks is safe and tolerable in people 50 and older with wet AMD.
-
AIV007 Periocular Shot for Wet AMD
This trial tests whether a periocular injection of AIV007 can improve vision and safety in people with wet age-related macular degeneration, compared with the standard Eylea injections.
-
Long-term follow-up for patients with wet age-related macular degeneration receiving SKG0106
This study is testing how well and safely the treatment SKG0106 works for people with wet age-related macular degeneration over a long period after their last injection.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.