Home › Trials › NCT07064759

Single intravitreal injection of 4D-150 for macular neovascularization from 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

Phase 3 Interventional 4D Molecular Therapeutics · NCT07064759

This trial will try a single eye injection of 4D-150 versus standard aflibercept in adults 50 and older with neovascular (wet) AMD to see if it controls disease activity.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment480 (estimated)
Ages50 Years and up
SexAll
Sponsor4D Molecular Therapeutics Industry-sponsored
Locations94 sites (Scottsdale, Arizona and 93 other locations)
Trial IDNCT07064759 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, double-masked, active-controlled trial comparing one intravitreal dose of the gene-therapy candidate 4D-150 to aflibercept injections in adults with macular neovascularization secondary to age-related macular degeneration. Eligible participants are adults aged 50 or older with imaging-confirmed active subfoveal or subfoveal-component lesions and either treatment-naive eyes or eyes with limited prior anti-VEGF exposure and documented response. Participants will be randomized to receive a single intravitreal administration of 4D-150 or an aflibercept injection, with masking maintained for participants and investigators. Efficacy and safety will be followed using visual function and retinal imaging endpoints at scheduled visits at the participating clinical sites.

Who should consider this trial

Good fit: Adults aged 50 or older with active macular neovascularization from AMD confirmed by fluorescein angiography or OCT, who are treatment-naive or have received no more than a few prior anti-VEGF injections with documented response, are ideal candidates.

Not a fit: Patients with long-standing scarring or extensive retinal damage, those who have not responded to prior anti-VEGF therapy, or people unable to attend required clinic visits are less likely to benefit from this approach.

Why it matters

Potential benefit: If successful, a single 4D-150 injection could provide durable control of neovascular activity and reduce the need for frequent anti-VEGF injections while maintaining or improving vision.

How similar studies have performed: Other AAV-based ocular gene therapies (for example RGX-314 and ADVM-022) produced promising early-phase results but have had mixed outcomes and no definitive, widely adopted Phase 3 success to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* ≥50 years of age at time of consent
* MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:

  1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
  2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
* 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
* CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center

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

Ocular Treatments/Interventions:

* Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye

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

Scottsdale, Arizona and 93 other locations

+44 more sites — see ClinicalTrials.gov for the full list.

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 → Find more trials like this →
Conditions Neovascular Age-Related Macular DegenerationAge-related macular degenerationAMDExudative AMDNeovascular AMDExudative age-related macular degenerationNeovascular age-related macular degenerationWet age-related macular degeneration
Last reviewed 2026-06-13 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.