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NCT01186432 Clinical Trial

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

Age-Related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01186432
Other study ID # FSV4 FH-1.2
Secondary ID
Status Completed
Phase Phase 1
First received August 19, 2010
Last updated March 4, 2015
Start date August 2010
Est. completion date April 2014

Study information
Verified date March 2015
Source Forsight Vision4
Contact n/a
Is FDA regulated No
Health authority Latvia: State Agency of Medicines
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2014
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PDS 1.0

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Forsight Vision4

Country where clinical trial is conducted

Latvia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in retinal thickness measured by Optical Coherence Tomography Monthly No
Secondary Change in Best Corrected Visual Acuity Monthly No
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