A Phase 1/2 Dose-Escalation and Randomized, Controlled, Masked Expansion Trial of Intravitreal 4D-150 Gene Therapy in Adults With Neovascular (Wet) Age-Related Macular Degeneration
Who is this study for? Adults with neovascular (wet) age-related macular degeneration
What treatments are being studied? 4D-150
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• S-1. ≥50 years of age S-2. Diagnosed with macular CNV secondary to AMD S-3. BCVA ETDRS Snellen equivalent between \
• 20/640 and 20/25 S-5. Currently receiving anti-VEGF and has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening
Locations
United States
Arizona
Barnet Delaney Perkins Eye Center
RECRUITING
Phoenix
California
California Retina Consultants
RECRUITING
Oxnard
Retinal Consultants Medical Group
RECRUITING
Sacramento
Colorado
Colorado Retina Associates
RECRUITING
Lakewood
Florida
Rand Eye Institute
RECRUITING
Deerfield Beach
Vitreo Retinal Associates
RECRUITING
Gainesville
Florida Eye Associates
RECRUITING
Melbourne
Retinal Specialty Institute
RECRUITING
Pensacola
Retina Vitreous Associates of Florida
RECRUITING
Tampa
Illinois
University Retina and Macula Associates
RECRUITING
Oak Forest
Indiana
Retina Partners Midwest
RECRUITING
Carmel
Massachusetts
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center
RECRUITING
Boston
Maryland
Cumberland Valley Retina Consultants
RECRUITING
Hagerstown
North Carolina
Western Carolina Retinal Associates
WITHDRAWN
Asheville
Nevada
Sierra Eye Associates
RECRUITING
Reno
Oregon
Verum Research, LLC
RECRUITING
Eugene
Pennsylvania
Mid Atlantic Retina
RECRUITING
Bethlehem
South Carolina
Palmetto Retina Center, LLC
RECRUITING
West Columbia
Tennessee
Tennessee Retina
RECRUITING
Nashville
Texas
Austin Clinical Research
RECRUITING
Austin
Valley Retina Institute, PA
RECRUITING
Mcallen
Retina Consultants of Texas
WITHDRAWN
The Woodlands
Washington
Pacific Northwest Retina LLC
WITHDRAWN
Bellevue
Other Locations
Puerto Rico
Emanuelli Research and Development Center, LLC
RECRUITING
Arecibo
Contact Information
Primary
4DMT Patient Advocacy
clinicaltrials@4DMT.com
(888) 748-8881
Time Frame
Start Date: 2021-12-09
Estimated Completion Date: 2031-01
Participants
Target number of participants: 215
Treatments
Experimental: 4D-150 Dose Escalation up to 4 dose levels
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Experimental: 4D-150 Dose Expansion Dose 1
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Experimental: 4D-150 Dose Expansion Dose 2
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Active_comparator: 4D-150 Dose Expansion Control
Aflibercept at a fixed regimen will be administered.
Experimental: 4D-150 Steroid Optimization
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Experimental: 4D-150 Population Extension Dose 1
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Experimental: 4D-150 Population Extension Dose 2
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Experimental: 4D-150 Population Extension Dose 3
4D-150 will be administered at the assigned dose
Experimental: 4D-150 Contralateral Eye Dose
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Experimental: 4D-150 Vector Shedding Dose
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Authors
Related Therapeutic Areas
Sponsors
Leads: 4D Molecular Therapeutics