4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration
Start Date
12/9/2021
Completion Date
1/1/2031
Summary
Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment. Substudies will evaluate the safety and tolerability of 4D-150 contralateral eye dosing and characterize vector shedding.
Detailed Description
This Phase 1/2 trial is a prospective, multicenter, Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment who have demonstrated a clinical response consistent with anti-VEGF activity. The trial consists of Dose Escalation, Dose Expansion, Steroid Optimization, and\[DD1.1\]\[JA1.2\] Population Extension Cohorts. After receiving one time administration of 4D-150 by intravitreal injection (IVT), subjects will undergo assessments at monthly intervals for 24 months to assess safety and efficacy outcomes. Only subjects that received 4D-150 will then enter a long-term follow-up (LTFU) period to assess long-term safety of 4D-150 gene therapy and duration of clinical activity through year 5 (60 months). Eligible subjects who received 4D-150 in the study eye may participate in a sub-study to evaluate one-time IVT administration of 4D-150 to the contralateral ("fellow") eye. Additional subjects will be enrolled in a separate sub-study to characterize the vector shedding profile of one-time administration of IVT 4D-150. In both sub-studies, subjects will undergo regular assessments to assess safety and tolerability through Week 52 and then will enter long-term follow-up for safety evaluation through year 5 (60 months).
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
4D-150 IVT
Aflibercept IVT
Conditions
Locations
Barnet Delaney Perkins Eye Center
Phoenix, Arizona 85016
United States
California Retina Consultants
Oxnard, California 93036
United States
Retinal Consultants Medical Group
Sacramento, California 95841
United States
Colorado Retina Associates
Lakewood, Colorado 80288
United States
Rand Eye Institute
Deerfield Beach, Florida 33064
United States
Retina Vitreous Consultants, LLP DBA Retina Group of Florida
Fort Lauderdale, Florida 33308
United States
Vitreo Retinal Associates
Gainesville, Florida 32607
United States
Florida Eye Associates
Melbourne, Florida 32901
United States
Retinal Specialty Institute
Pensacola, Florida 32503
United States
Retina Vitreous Associates of Florida
Tampa, Florida 33607
United States
University Retina and Macula Associates
Oak Forest, Illinois 60452
United States
Retina Partners Midwest
Carmel, Indiana 46290
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United States
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center
Boston, Massachusetts 02114
United States
Sierra Eye Associates
Reno, Nevada 89502
United States
Western Carolina Retinal Associates
Asheville, North Carolina 28803
United States
Verum Research, LLC
Eugene, Oregon 97401
United States
Mid Atlantic Retina
Bethlehem, Pennsylvania 18017
United States
Palmetto Retina Center, LLC
West Columbia, South Carolina 29169
United States
Tennessee Retina
Nashville, Tennessee 37203
United States
Austin Clinical Research
Austin, Texas 78750
United States
Valley Retina Institute, PA
McAllen, Texas 78503
United States
Retina Consultants of Texas
The Woodlands, Texas 77384
United States
Pacific Northwest Retina LLC
Bellevue, Washington 98004
United States
Emanuelli Research and Development Center, LLC
Arecibo, Puerto Rico 00612
Puerto Rico