- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326259
Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this research is to conduct a study that investigates (1) how diabetic retinopathy progresses when poorly controlled Type 2 diabetic patients initiate intensive blood sugar control and (2) to determine if there are biomarkers that predict progression of diabetic retinopathy. Typically, the retina is thought to undergo rapid progression of diabetic retinopathy, although this has been poorly characterized in a formal study.
The first goal will be quantified by taking initial photos of the retina with the Pictor Plus hand-held fundus camera, as well as monthly photos (when the patient is scheduled for their endocrinology appointments, throughout a 90 day period). The second goal will be accomplished by testing the patient's blood. There will be an initial blood withdraw, as well as blood withdraws at monthly intervals throughout the same 90 day period as the fundus photos.
This study will help us to understand the pathogenesis of diabetic retinopathy, as well as potentially lead to an improved understanding of progression of diabetic retinopathy.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Presenting to the endocrinology clinic with a hemoglobin A1c of greater than 12.
Exclusion Criteria:
- Patients with other ocular or systemic conditions, including macular degeneration, uveitis, glaucoma, and autoimmune conditions (Rheumatoid Arthritis, Lupus, and other similar conditions).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression of diabetic retinopathy
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William J Foster, MD, PhD, Temple University
- Principal Investigator: Ajay D Rao, MD, MMSc, FACP, Temple University
- Principal Investigator: Raul A DeLa Cadena, MD, Temple University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Eye Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Hyperglycemia
- Disease Progression
- Retinal Diseases
- Diabetic Retinopathy
Other Study ID Numbers
- 22531
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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