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

This study has been completed.

Sponsor:

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

History of Changes

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Best Corrected Visual Acuity [ Time Frame: Monthly ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
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

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
Health Authority:	Latvia: State Agency of Medicines

Additional relevant MeSH terms:


Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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