Back to resultsPreliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
Latvia
Study Type
Interventional
Intervention
PDS 1.0
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
ranibizumab sustained delivery implant
Outcomes
Primary Outcome Measures
Change in retinal thickness measured by Optical Coherence Tomography
Secondary Outcome Measures
Change in Best Corrected Visual Acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01186432
Brief Title
Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forsight Vision4
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
ranibizumab sustained delivery implant
Intervention Type
Drug
Intervention Name(s)
PDS 1.0
Primary Outcome Measure Information:
Title
Change in retinal thickness measured by Optical Coherence Tomography
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity
Time Frame
Monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Riga
Country
Latvia
12. IPD Sharing Statement
Learn more about this trial
Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)
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