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Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
triamcinolone acetonide (Kenalog)
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, fluorescein angiography, steroid, anti-angiogenesis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Cole Eye Institute

Outcomes

Primary Outcome Measures

Change in retinal vascular density from baseline on fluorescein angiography

Secondary Outcome Measures

Safety

Full Information

First Posted
December 13, 2006
Last Updated
November 9, 2010
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00411333
Brief Title
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy
Official Title
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

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.
Detailed Description
In this study, we are studying whether vascular density decreases during diabetic retinopathy prior to the pathological neovascularization seen in proliferative disease that results in blindness in more than 50 percent of patients, and whether the adverse, early vascular remodeling and neovascularization can be reversed by anti-angiogenic therapeutics. We have shown that vascular density decreases during early stages of diabetic retinopathy, prior to the pathological neovascularization that defines proliferative retinopathy, and that this change may be reversible with new anti-angiogenic therapeutics. To test this hypothesis we will determine (1) how blood vessels remodel and whether vascular density truly decreases during diabetic retinopathy and (2) how the anti-angiogenic steroid triamcinolone acetonide affects vascular density and pattern during human diabetic retinopathy and in our experimental model, the avian CAM model. Twenty patients (n = 20) for each of the 4 NPDR stages will be enrolled. In addition, a control group of 20 normal subjects will be recruited from the same clinical practice that do not have diabetes and no evidence of any vascular disease, for a total of 100 patients in the clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy, fluorescein angiography, steroid, anti-angiogenesis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide (Kenalog)
Primary Outcome Measure Information:
Title
Change in retinal vascular density from baseline on fluorescein angiography
Secondary Outcome Measure Information:
Title
Safety

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter K Kaiser, MD
Organizational Affiliation
Cole Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19797226
Citation
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.
Results Reference
result
PubMed Identifier
19248164
Citation
Vickerman 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.
Results Reference
result

Learn more about this trial

Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

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