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Treatment for wet age-related macular degeneration using 4D-150

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

PHASE1; PHASE2 · 4D Molecular Therapeutics · NCT05197270

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
Enrollment215 (estimated)
Ages50 Years and up
SexAll
Sponsor4D Molecular Therapeutics (industry)
Drugs / interventionsranibizumab, faricimab, bevacizumab
Locations25 sites (Phoenix, Arizona and 24 other locations)
Trial IDNCT05197270 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While gene therapy approaches for AMD are being explored, this specific intervention is novel and has not been widely tested in previous studies.

Eligibility criteria

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 Screening) 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 screening) 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 this trial is running

Phoenix, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Neovascular Age-Related Macular Degeneration, Age-related macular degeneration, AMD, Exudative AMD, Exudative age-related macular degeneration, Neovascular AMD, Neovascular age-related macular degeneration, Wet age-related macular degeneration

Last reviewed 2026-05-15 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.