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Active, Not Recruiting

NCT Number: NCT06864988

4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Calgary Retina Consultants, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥50 years of age at time of consent
  • Treatment naïve MNV secondary to nAMD in the study eye
  • 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

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

Treatment and study plan

4D-150 IVT (3E10 vg/eye)

Biological

If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1

EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Biological

Eylea (aflibercept) will be administered at applicable visits

Primary outcomes

  1. Mean change from baseline in BCVA ETDRS letter score at Week 52

    Time frame: 52 Weeks

Secondary outcomes

  1. Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104

    Time frame: 104 Weeks

  2. Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104

    Time frame: 104 Weeks

  3. Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm

    Time frame: 104 Weeks

  4. Mean change from baseline in CST over time through Weeks 52 and 104

    Time frame: 104 Weeks

  5. Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104

    Time frame: 104 Weeks

Sponsors and collaborators

Lead sponsor

4D Molecular Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 7, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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