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

Conditions

Macular Neovascularization Secondary to Age-Related Macular Degeneration

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Study Overview

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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

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

Phoenix

Barnet Dulaney Perkins Eye Center, Phoenix, Arizona, United States, 85016

Scottsdale

Retinal Research Institute, LLC, Scottsdale, Arizona, United States, 85254

Springdale

Retina Partners of Northwest Arkansas, Springdale, Arkansas, United States, 72764

Bakersfield

California Retina Consultants, Bakersfield, California, United States, 93309

Beverly Hills

Retina Vitreous Associates Medical Group, Beverly Hills, California, United States, 90211

Encino

The Retina Partners, Encino, California, United States, 91436

Huntington Beach

Retina Associates of Southern California, Huntington Beach, California, United States, 92647

Loma Linda

Loma Linda University Faculty Medical Clinics, Loma Linda, California, United States, 92354

Los Angeles

Jules Stein Eye Institute, Los Angeles, California, United States, 90095

Mountain View

Northern California Retina Vitreous Associates, Mountain View, California, United States, 94040

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
  • * 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
  • * 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
  • * 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,

Hersh Patel, STUDY_DIRECTOR, 4D Molecular Therapeutics

Study Record Dates

2028-06