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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nagoya University Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Hyogo Prefectural Amagasaki General Medical Center
  Hyōgo, Amagasaki-Shi, Japan Recruiting
• Fukushima Medical University Hospital
  Fukushima, Fukushima, Japan Recruiting
• Kozawa Eye Hospital and Diabetes Center
  Mito, Ibaraki, Japan Recruiting
• University of Miyazaki Hospital
  Miyazaki, Miyazaki, Japan Recruiting
• University of the Ryukyus Hospital
  Ginowan, Okinawa, Japan Recruiting

+76 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: 4DMT Patient Advocacy
• Email: clinicaltrials@4DMT.com
• Phone: (888) 748-8881

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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.