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

Arm | Intervention/treatment |
---|---|
Experimental: Active
ranibizumab sustained delivery implant
|
Drug: PDS 1.0 |
- Change in retinal thickness measured by Optical Coherence Tomography [ Time Frame: Monthly ]
- Change in Best Corrected Visual Acuity [ Time Frame: Monthly ]

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

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
Latvia | |
Riga, Latvia |
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 |