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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:
Forsight Vision4
Information provided by (Responsible Party):
Forsight Vision4
ClinicalTrials.gov Identifier:
NCT01186432
First received: August 19, 2010
Last updated: March 4, 2015
Last verified: March 2015
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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: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
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| 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
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: NCT01186432
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | August 19, 2010 |
| Last Updated: | March 4, 2015 |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on August 16, 2017