Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014