RECRUITING

Single Intravitreal Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Description

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

Study Overview

Study Details

Study overview

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

Single Intravitreal Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Condition
Macular Neovascularization Secondary to Age-Related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Sun City

Barnet Dulaney Perkins Eye Center, Sun City, Arizona, United States, 85351

Hagerstown

Cumberland Valley Retina Consultants, Hagerstown, Maryland, United States, 21740

Nashville

Tennessee Retina, PC, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

4D Molecular Therapeutics,

Julie Tsai, MD, STUDY_DIRECTOR, 4D Molecular Therapeutics

Study Record Dates

2029-02