Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00411333
Recruitment Status : Completed
First Posted : December 14, 2006
Last Update Posted : November 11, 2010
Information provided by:
National Eye Institute (NEI)

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: triamcinolone acetonide (Kenalog) Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy
Study Start Date : July 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in retinal vascular density from baseline on fluorescein angiography

Secondary Outcome Measures :
  1. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00411333

United States, Ohio
Cole Eye Institute
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
National Eye Institute (NEI)
Principal Investigator: Peter K Kaiser, MD Cole Eye Institute

Publications of Results: Identifier: NCT00411333     History of Changes
Other Study ID Numbers: R01 EY017528-0
First Posted: December 14, 2006    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by National Eye Institute (NEI):
diabetic retinopathy
fluorescein angiography

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Vascular Remodeling
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathological Conditions, Anatomical
Pathologic Processes
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action