Status:
RECRUITING
4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration
Lead Sponsor:
4D Molecular Therapeutics
Conditions:
Neovascular (Wet) Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief 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-1...
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 d...
Eligibility Criteria
Inclusion
- 50 years of age
- Diagnosed with macular CNV secondary to AMD
- BCVA ETDRS Snellen equivalent for dose escalation and contralateral eye between \~20/32 and \~20/320, or for dose expansion and population extension between \~20/25 and\~20/200, for steroid optimization and shedding sub-study 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
- Contralateral Eye Sub-study-Specific Criteria: Received 4D-150 in study eye-1 at least 6 months prior to Contralateral Sub-study Screening Visit
- Contralateral Eye Sub-study-specific Exclusion: Prior adverse event related to 4D-150, required modifications to or reinitiated protocol specified corticosteroid regimen/taper in study eye-1, signs and symptoms of noninfectious intraocular inflammation in either eye
- \-
- Shedding Sub-study-specific
- 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
- Shedding Sub-study-specific
Exclusion
- 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
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT05197270
Start Date
December 9 2021
End Date
January 1 2031
Last Update
September 15 2025
Active Locations (24)
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1
Barnet Delaney Perkins Eye Center
Phoenix, Arizona, United States, 85016
2
California Retina Consultants
Oxnard, California, United States, 93036
3
Retinal Consultants Medical Group
Sacramento, California, United States, 95841
4
Colorado Retina Associates
Lakewood, Colorado, United States, 80288