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Summary
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
NCTID
NCT07064759
(View at clinicaltrials.gov)
Description
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
(Show More)
Development Status
Active
Indication
Neovascular Age-Related Macular Degeneration (nAMD)
Disease Ontology Term
DOID:10871
Compound Name
4D-150
Sponsor
4D Molecular Therapeutics
Funder Type
Industry
Recruitment Status
Recruiting
(Click here for study contact information)
Enrollment Count
400 (ESTIMATED)
Results Posted
Not Available
Therapy Information
Target Gene/Variant
Anti-VEGF
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Genetic delivery of therapeutic protein
Route of Administration
Intravitreal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV
Editor Type
none
Dose 1
Phase 1/2 doses: 1E10 vg/eye, 3E10 vg/eye
Dose 2
Phase 3 dose: 3E10 vg/eye
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase3
Submit Date
2025-07-07
Completion Date
2029-02
Last Update
2025-10-20
Participation Criteria
Eligible Age
>=50 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
24
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Regenerative Medicine Advanced Therapy
Recent Updates
4D-150 is also being evaluated for the treatment of Diabetic macular edema in a Phase 2 trial (NCT05930561)
Resources/Links
Clinical Publications
(Presentation) Extended Follow-Up in the PRISM Clinical Trial Evaluating 4D-150 in Adults with Neovascular Age-related Macular Degeneration - Angiogenesis 2025
(Corporate Presentation) 4D-150: PRISM Phase 2b 52-week Topline Data in Wet AMD and Program Update - February 2025
(Corporate Presentation) 4D-150 Business & PRISM Wet AMD Long-term Data Update
(Presentation) Extended Follow-Up in the PRISM Clinical Trial Evaluating 4D-150 in Adults with Neovascular Age-related Macular Degeneration - EURETINA 2024
(Corporate Presentation) Intravitreal 4D-150: Phase 2 Population Extension in Broad Disease Activity Wet AMD Patients - July 2024
News and Press Releases
SEC Form 10-Q: 4D Molecular Therapeutics, Inc. Q3 2024
4DMT Announces Positive Long-Term Data from Phase 1/2 PRISM Clinical Trial in Wet AMD Supporting 4D-150’s Potential as a Backbone Therapy with Consistent and Durable Benefit over Multiple Years
4DMT Focuses Pipeline to Prioritize 4D-150 in Wet AMD & DME
Preclinical Publications
Design and Characterization of a Novel Intravitreal Dual-Transgene Genetic Medicine for Neovascular Retinopathies
Related NCTID
Phase 1/2: NCT05197270
Phase 3: NCT06864988