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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Forsight Vision4
ClinicalTrials.gov Identifier:
NCT01177644
First received: August 5, 2010
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Age-Related Macular Degeneration
Drug: PDS 1.0
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Forsight Vision4:

Primary Outcome Measures:
  • Change in retinal thickness measured by Optical Coherence Tomography [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Best Corrected Visual Acuity [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: PDS 1.0

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177644

Locations
Israel
Tel Aviv, Israel
Sponsors and Collaborators
Forsight Vision4
  More Information

No publications provided

Responsible Party: Forsight Vision4
ClinicalTrials.gov Identifier: NCT01177644     History of Changes
Other Study ID Numbers: FSV4 FH-1
Study First Received: August 5, 2010
Last Updated: August 21, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014