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Sponsors and Collaborators: |
Penn State University Juvenile Diabetes Research Foundation |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00511875 |
This 24 month randomized research study will evaluate whether doxycycline can 1) slow the deterioration or improve retinal function and/or 2) induce regression, or slow progression, of diabetic retinopathy in participants over 18 years of age with type 1 or type 2 diabetes with severe non-proliferative or early proliferative diabetic retinopathy.
Condition | Intervention | Phase |
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Diabetic Retinopathy |
Drug: doxycycline monohydrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Effect of Doxycyline Verses Placebo on Diabetic Retinopathy Progression and Retinal Function in Patients With Severe Non-Proliferative or Mild or Moderate (Non-High-Risk) Proliferative Diabetic Retinopathy |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
stratified equally to either doxycycline monohydrate 50mg or placebo taken once daily for 24 months
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Drug: doxycycline monohydrate
50mg once daily for 24 months
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The objectives of this proof-of-concept study are to investigate whether doxycycline can 1) slow the deterioration or improve retinal function and/or 2) induce regression, or slow progression, of diabetic retinopathy. The tests will be performed in the Ophthalmology Departments of the Penn State College of Medicine and Glostrup Hospital, Copenhagen, Denmark. The 24 month proof-of-concept clinical study will involve a prospective, randomized, double-masked clinical trial including 60 adult patients with type 1 or type 2 diabetes who have severe non-proliferative diabetic retinopathy (ETDRS level 53E) or mild or moderate proliferative diabetic retinopathy (retinal and /or optic disk neovascularization less than the "high-risk" ETDRS level 61 or 65), neovascularization of the disc or neovascularization elsewhere >1/2 disc area and in whom panretinal photocoagulation is not imminently required in the ophthalmologist's judgment.
Systemic Exclusion Criteria:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Ingrid U Scott, MD MPH 717-531-4662 iscott@hmc.psu.edu | |
Contact: Thomas W Gardner, MD MS 717-531-5817 tgardner@psu.edu | |
Principal Investigator: Ingrid U Scott, MD MPH | |
Sub-Investigator: Thomas W Gardner, MD MS | |
Sub-Investigator: David A Quillen, MD | |
Sub-Investigator: Kimberly A Neely, MD Phd | |
Sub-Investigator: Michael Larsen, MD DMSc | |
Sub-Investigator: Allen R Kunselman | |
Sub-Investigator: Gregory R Jackson, PhD |
Study Director: | Thomas W Gardner, MD MS | Penn State University, Milton S. Hershey Medical Center |
Principal Investigator: | Ingrid U Scott, MD MPH | Penn State University, Milton S Hershey Medical Center |
Responsible Party: | Penn State ( Ingrid U Scott MD MPH ) |
Study ID Numbers: | 25234 |
Study First Received: | August 3, 2007 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00511875 |
Health Authority: | United States: Food and Drug Administration |
diabetic retinopathy diabetes diabetic eye studies neovascularization |
Diabetic Retinopathy Eye Diseases Vascular Diseases Disease Progression Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Neovascularization, Pathologic Doxycycline Diabetes Complications Retinal Diseases Diabetic Angiopathies |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Therapeutic Uses Cardiovascular Diseases Pharmacologic Actions |