Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy
2 other identifiers
interventional
100
1 country
1
Brief Summary
The retinal vasculature changes dramatically in patients with diabetic retinopathy especially between non-proliferative and proliferative disease. The retinal vasculature can be imaged and quantified using special dyes. This study will test whether the pattern of the retinal vasculature changes in patients with different levels of diabetic retinopathy can be quantified using computerized image analysis. In addition, the study will evaluate whether new drugs to treat diabetic retinopathy will be able to reverse these vascular changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jul 2006
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedNovember 11, 2010
November 1, 2010
3 years
December 13, 2006
November 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in retinal vascular density from baseline on fluorescein angiography
Secondary Outcomes (1)
Safety
Interventions
Eligibility Criteria
You may qualify if:
- \- Presence of mild, moderate, severe, or very severe non-proliferative diabetic retinopathy (defined as ETDRS level \>10) in at least one eye (based on ETDRS criteria)
You may not qualify if:
- Any condition that might impair the patient's ability to give informed consent
- Any condition or media opacity that might impair the patient's ability to perform vision tests, color fundus photographs or fluorescein angiography
- Severe allergy or other contraindication to sodium fluorescein dye
- Participating in any other ophthalmic clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cole Eye Institute
Cleveland, Ohio, 44195, United States
Related Publications (2)
Parsons-Wingerter P, Radhakrishnan K, Vickerman MB, Kaiser PK. Oscillation of angiogenesis with vascular dropout in diabetic retinopathy by VESsel GENeration analysis (VESGEN). Invest Ophthalmol Vis Sci. 2010 Jan;51(1):498-507. doi: 10.1167/iovs.09-3968. Epub 2009 Sep 24.
PMID: 19797226RESULTVickerman MB, Keith PA, McKay TL, Gedeon DJ, Watanabe M, Montano M, Karunamuni G, Kaiser PK, Sears JE, Ebrahem Q, Ribita D, Hylton AG, Parsons-Wingerter P. VESGEN 2D: automated, user-interactive software for quantification and mapping of angiogenic and lymphangiogenic trees and networks. Anat Rec (Hoboken). 2009 Mar;292(3):320-32. doi: 10.1002/ar.20862.
PMID: 19248164RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter K Kaiser, MD
Cole Eye Institute
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 13, 2006
First Posted
December 14, 2006
Study Start
July 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
November 11, 2010
Record last verified: 2010-11