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

Phase 1

Withdrawn

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: PDS 1.0

• Registration Number: NCT01177644
• Lead Sponsor: Forsight Vision4

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-09
• Study Start: 2011-01
• Primary Completion: 2011-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	PDS 1.0	-

Primary Outcome Measures

Name	Time	Method
Change in retinal thickness measured by Optical Coherence Tomography	Monthly

Secondary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity	Monthly