Trial record 5 of 310 for:    "Diabetic Retinopathy"

Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy (POC2)

This study has been completed.
Sponsor:
Collaborators:
Penn State University
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Thomas W. Gardner, Penn State University
ClinicalTrials.gov Identifier:
NCT00917553
First received: June 1, 2009
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

This 24 month randomized research study will evaluate whether doxycycline can slow the deterioration or improve retinal function among patients with mild to moderate non-proliferative diabetic retinopathy.


Condition Intervention Phase
Diabetic Retinopathy
Drug: doxycycline monohydrate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Proof-of-Concept 2 (POC2): Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy Progression in Patients With Mild to Moderate Non-Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • The mean change in the foveal sensitivity of Matrix frequency doubling perimetry (FDP) from baseline in the treated group compared to the placebo group [ Time Frame: From baseline to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The functional and anatomic outcomes will be assessed by comparing the placebo group with the treated group in this proof-of-concept study in the following procedures; visual functions tests, fundus photography and optical coherence. [ Time Frame: The secondary outcome measures will be assessed from baseline to 24 months. ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: July 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxycycline monohydrate Drug: doxycycline monohydrate
50 mg
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Cellulose Placebo Capsule

Detailed Description:

The objective of this proof-of-concept study is to investigate whether doxycycline can slow the deterioration or improve retinal function among patients with mild to moderate NPDR (with abnormal retinal function defined as a foveal sensitivity < 30.91 dB on Matrix frequency doubling perimetry [FDP]). Based on results of the END DR Study, the primary visual function endpoint in the POC 2 Study will be performance on the Matrix Frequency Doubling Technology Perimeter. This test was the most sensitive to NPDR of the visual function endpoints the investigators evaluated in the END DR Study. This selection is aggressive because the investigators lack natural history data to estimate the 2-year rate of change in the endpoint; in fact, a major output of this POC 2 Study will be 2-year natural history data using several visual function endpoints. The investigators are enrolling patients who have moderate dysfunction; that is, patients who fall outside the 95% confidence interval of normal performance on FDP. These patients will have the opportunity to improve their FDP performance to "normal" levels as well as progress to more severe FDP impairment associated with more advanced disease. Secondary endpoints include visual acuity, contrast sensitivity, visual field, and dark adaptation. The tests will be performed in the Ophthalmology Department of the Penn State College of Medicine. 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 mild to moderate NPDR (ETDRS levels 20 to 43), and in whom retinal photocoagulation is not anticipated (by the investigator) within the subsequent 2 years. Participants will be randomized to receive either doxycycline monohydrate 50mg or an identical placebo once daily for 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years old
  • diagnosis of type 1 or type 2 diabetes mellitus (defined as current regular use of oral anti-hyperglycemia agents and/or insulin for the treatment of diabetes)
  • have a hemoglobin A1c < 11% at pre-qualification visit
  • able and willing to give informed consent
  • best-corrected ETDRS visual acuity (10) in study eye ≥ 69 letters (20/40)
  • mild to moderate non-proliferative diabetic retinopathy (ETDRS levels 20 to 43) (11), and in whom retinal photocoagulation is not anticipated (by the investigator) within the subsequent 2 years
  • able to perform reliable visual field and dark adaptation testing
  • central subfield thickness on OCT ≤ 275 microns
  • media clarity and pupil dilation sufficient for high-quality fundus photographs
  • abnormal retinal function defined as:
  • abnormal FDP function as defined by a foveal sensitivity ≤ 30.91 dB

Exclusion Criteria:

  • prior panretinal photocoagulation in the study eye
  • prior focal/grid laser photocoagulation in the macula in the study eye
  • intraocular pressure in the study eye > 22 mmHg by Goldmann tonometry
  • history of pars plana vitrectomy in the study eye
  • systemic or intravitreal anti-VEGF agent to the study eye or the fellow eye within the past 3 months
  • peribulbar steroid injection to the study eye or the fellow eye within the past 6 months
  • intravitreal triamcinolone acetonide to the study eye within the past 4 months
  • expectation by the investigator that retinal photocoagulation or other treatment for diabetic retinopathy (e.g., focal/grid laser to study eye, intravitreal triamcinolone acetonide to study eye, intravitreal anti-VEGF agent to study or fellow eye, ruboxistaurin or systemic anti-VEGF agent for diabetic macular edema) will be administered in the subsequent 24months
  • an ocular condition (other than diabetes) is present in the study eye that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc)
  • anticipated need for cataract surgery in the study eye in the subsequent 24 months in the opinion of the investigator
  • history of major ocular surgery (including cataract surgery, scleral buckle, any intraocular surgery, etc) in the study eye within prior 6 months or anticipated within the subsequent 24 months following randomization
  • aphakia in the study eye
  • history of YAG capsulotomy performed in the study eye within 2 months prior to randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917553

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Thomas W. Gardner
Penn State University
Juvenile Diabetes Research Foundation
Investigators
Study Director: Thomas W Gardner, MD.,MS. University of Michigan, Kellogg Eye Center
  More Information

No publications provided

Responsible Party: Thomas W. Gardner, Thomas W. Gardner, MD, Penn State University
ClinicalTrials.gov Identifier: NCT00917553     History of Changes
Other Study ID Numbers: 30791
Study First Received: June 1, 2009
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Penn State University:
diabetic retinopathy
diabetes
diabetic eye studies

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 26, 2014