Safety and Preliminary Efficacy Study of PDS-1.0 in Patients With Neovascular AMD

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients with neovascular AMD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forsight Vision4

Criteria

Key Inclusion Criteria:

• Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated

• Retinal thickness due to edema of at least 300um in the study eye

• Best corrected visual acuity of 20/80 or worse in the study eye

• Best corrected visual acuity of 20/40 or better in the fellow eye

Exclusion Criteria:

• Evidence of scarring CNV (e.g. geographic atrophy) in the study eye

• Fibrosis >75% of lesion area in the study eye