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

Age-Related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01177644
• Other study ID #: FSV4 FH-1
• Status: Withdrawn
• Phase: Phase 1
• First received: August 5, 2010
• Last updated: August 21, 2012
• Start date: January 2011

Study information

• Verified date: August 2012
• Source: Forsight Vision4
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

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

Israel, 

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