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Clinical Trial Summary

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05197270
Study type Interventional
Source 4D Molecular Therapeutics
Contact 4DMT Patient Advocacy
Phone (888) 748-8881
Email clinicaltrials@4DMT.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 9, 2021
Completion date November 2025

See also
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Completed NCT04847895 - Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications
Active, not recruiting NCT05439629 - Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration Phase 3
Terminated NCT05473715 - A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment Phase 4
Recruiting NCT06346600 - A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD