Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)

Phase 1

Completed

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

• Registration Number: NCT01186432
• Lead Sponsor: Forsight Vision4

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2012-05
• Study Completion: 2014-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 20/40 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	ranibizumab sustained delivery implant

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