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

NCT00917553 | Completed Phase 2 Results DMC

• 1 other identifier: 30791
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy; diabetes; diabetic eye studies

Outcome Measures

Primary Outcomes (1)

• The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group

  Baseline and 24 months

Secondary Outcomes (4)

• Change Thickness Thickness

  Baseline and 24 months

• Change in Macular Volume

  Baseline and 24 months

• Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level

  Baseline to 24 months

• Number of Participants Who Developed Vitreous or Preretinal Hemorrhage

  24 months

Study Arms (2)

doxycycline monohydrate

EXPERIMENTAL

Drug: doxycycline monohydrate

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

doxycycline monohydrate DRUG

50 mg

doxycycline monohydrate

Placebo DRUG

Cellulose Placebo Capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Gardner: lead
• Penn State University: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Scott IU, Jackson GR, Quillen DA, Klein R, Liao J, Gardner TW. Effect of doxycycline vs placebo on retinal function and diabetic retinopathy progression in mild to moderate nonproliferative diabetic retinopathy: a randomized proof-of-concept clinical trial. JAMA Ophthalmol. 2014 Sep;132(9):1137-42. doi: 10.1001/jamaophthalmol.2014.1422.

  PMID: 24969516 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Thomas W. Gardner
• Organization: University of Michigan

tomwgard@med.umich.edu

734 232-8404

Study Officials

• Thomas W Gardner, MD.,MS.

  University of Michigan, Kellogg Eye Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thomas W. Gardner, MD

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 10, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 30, 2018
• Results First Posted: November 30, 2018

Record last verified: 2018-10

Locations

US (1)