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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186432
First Posted: August 23, 2010
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forsight Vision4
  Purpose
This study will evaluate the preliminary safety and efficacy 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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: April 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
ranibizumab sustained delivery implant
Drug: PDS 1.0

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Responsible Party: Forsight Vision4
ClinicalTrials.gov Identifier: NCT01186432     History of Changes
Other Study ID Numbers: FSV4 FH-1.2
First Submitted: August 19, 2010
First Posted: August 23, 2010
Last Update Posted: March 5, 2015
Last Verified: March 2015

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