Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy (NCT00917553) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy
United States33 participantsStarted 2009-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
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