4D-150 in Patients with Neovascular (Wet) Age-Related Macular Degeneration
- Conditions
- Neovascular (Wet) Age-Related Macular Degeneration
- Interventions
- Biological: 4D-150 IVT
- Registration Number
- NCT05197270
- Lead Sponsor
- 4D Molecular Therapeutics
- Brief Summary
Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment
- 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 Population Extension Cohorts.
After receiving one time administration of 4D-150 by intravitreal injection, 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 215
- ≥50 years of age
- Diagnosed with macular CNV secondary to AMD
- BCVA ETDRS Snellen equivalent for dose escalation between ~20/32 and ~20/320, or for dose expansion and population extension between ~20/25 and~20/200, for steroid optimization between ~20/25 and ~20/640
- Currently receiving anti-VEGF treatment in the study eye and has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening
- Any condition preventing visual acuity improvement in the study eye
- Prior treatment with photodynamic therapy or retinal laser in the study eye
- History of uveitis in either eye
- Any other pre-existing eye conditions or surgical complications that would preclude participation in an interventional clinical trial or interfere with the interpretation of study endpoints
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 4D-150 Dose Expansion Control Aflibercept IVT Aflibercept at a fixed regimen will be administered. 4D-150 Population Extension Dose 3 4D-150 IVT 4D-150 will be administered at the assigned dose 4D-150 Dose Escalation up to 4 dose levels 4D-150 IVT 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. 4D-150 Dose Expansion Dose 1 4D-150 IVT 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. 4D-150 Dose Expansion Dose 2 4D-150 IVT 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. 4D-150 Steroid Optimization 4D-150 IVT 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. 4D-150 Population Extension Dose 1 4D-150 IVT 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. 4D-150 Population Extension Dose 2 4D-150 IVT 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
- Primary Outcome Measures
Name Time Method Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant changes in safety parameters 52 weeks
- Secondary Outcome Measures
Name Time Method Time to receiving the first supplemental aflibercept injection 52 weeks Percentage of subjects requiring supplemental aflibercept injections over 52 weeks 52 weeks Change from baseline in BCVA over time (up to 52 weeks) as assessed using the ETDRS Visual Acuity Chart 52 weeks Number of supplemental aflibercept injections over 52 weeks 52 weeks Change from baseline in central subfield thickness (CST) over time (up to 52 weeks) measured by spectral domain optical coherence tomography (SD-OCT) 52 weeks
Trial Locations
- Locations (24)
Barnet Delaney Perkins Eye Center
🇺🇸Phoenix, Arizona, United States
California Retina Consultants
🇺🇸Oxnard, California, United States
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States
Colorado Retina Associates
🇺🇸Lakewood, Colorado, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Vitreo Retinal Associates
🇺🇸Gainesville, Florida, United States
Retinal Specialty Institute
🇺🇸Pensacola, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Tampa, Florida, United States
University Retina and Macula Associates
🇺🇸Oak Forest, Illinois, United States
Retina Partners Midwest
🇺🇸Carmel, Indiana, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center
🇺🇸Boston, Massachusetts, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Western Carolina Retinal Associates
🇺🇸Asheville, North Carolina, United States
Verum Research, LLC
🇺🇸Eugene, Oregon, United States
Mid Atlantic Retina
🇺🇸Bethlehem, Pennsylvania, United States
Palmetto Retina Center, LLC
🇺🇸West Columbia, South Carolina, United States
Tennessee Retina
🇺🇸Nashville, Tennessee, United States
Austin Clinical Research
🇺🇸Austin, Texas, United States
Valley Retina Institute, PA
🇺🇸McAllen, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Pacific Northwest Retina LLC
🇺🇸Bellevue, Washington, United States
Emanuelli Research and Development Center, LLC
🇵🇷Arecibo, Puerto Rico