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

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ClinicalTrials.gov Identifier: NCT01177644
Recruitment Status : Withdrawn
First Posted : August 9, 2010
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Forsight Vision4

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

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: PDS 1.0 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Estimated Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Drug: PDS 1.0



Primary Outcome Measures :
  1. Change in retinal thickness measured by Optical Coherence Tomography [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. Change in Best Corrected Visual Acuity [ Time Frame: Monthly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177644


Locations
Israel
Tel Aviv, Israel
Sponsors and Collaborators
Forsight Vision4

Responsible Party: Forsight Vision4
ClinicalTrials.gov Identifier: NCT01177644     History of Changes
Other Study ID Numbers: FSV4 FH-1
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

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