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

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ClinicalTrials.gov Identifier: NCT01186432
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Forsight Vision4

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will evaluate the preliminary safety and efficacy 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
ranibizumab sustained delivery implant
 Drug: PDS 1.0


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01186432


Locations
Latvia
Riga, Latvia
Sponsors and Collaborators
Forsight Vision4
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Forsight Vision4
ClinicalTrials.gov Identifier: NCT01186432     History of Changes
Other Study ID Numbers: FSV4 FH-1.2
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

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