Trial | NCT01186432  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD.
Study Started
Aug 31
2010
Primary Completion
May 31
2012
Study Completion
Apr 30
2014
Last Update
Mar 05
2015
Estimate

Drug PDS 1.0

Active Experimental

ranibizumab sustained delivery implant

Criteria 

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
No Results Posted