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
4D Molecular Therapeutics
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.
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 subje…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
* 50 years of age Individuals eligible to participate in the trial must meet the following inclusion criteria: 1. ≥50 years of age 2. Diagnosed with CNV secondary to AMD (confirmed by reading center) 3. BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye, and BCVA in the study eye: 4. Central subfield thickness (CST) and/or presence of subretinal or intraretinal fluid requiring continued anti-VEGF therapy in the study eye, as assessed by SD-OCT; and confirmed by a reading center): 5. Study eye amenable to IVT injection 6. Ability to perform tests of visual and retinal function and str…
Interventions
- Biological4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
- BiologicalAflibercept IVT
Commercially available Active Comparator Other Name: Eylea
Locations (25)
- Barnet Delaney Perkins Eye CenterPhoenix, Arizona
- California Retina ConsultantsOxnard, California
- Retinal Consultants Medical GroupSacramento, California
- Colorado Retina AssociatesLakewood, Colorado
- Rand Eye InstituteDeerfield Beach, Florida
- Retina Vitreous Consultants, LLP DBA Retina Group of FloridaFort Lauderdale, Florida