Clinical trial Recruiting at 21 sites Phase1; Phase2 Interventional Ages 50 and up

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

PhasePhase1; Phase2
Study typeInterventional
Ages50 Years and up
SexAll
Enrollment215 (estimated)
Sponsor4D Molecular Therapeutics
Industry-sponsored
Drugs / interventionsranibizumab, faricimab, bevacizumab
Locations26 sites (Phoenix, Arizona and 25 other locations)
StatusRecruiting
StartedDecember 9, 2021
Main results expectedMarch 2027
Study endsJanuary 2031
Registry record updatedAugust 21, 2026
Trial IDNCT05197270 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.