Phase 2
N=30
Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy
Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT00511875 ↗Enrolled (actual)
30
Serious AEs
20.0%
Results posted
Nov 2018
Primary outcome: Primary: Change in Dark Adaptation, Rod Intercept — 0.3; -0.3 minutes — p=.70
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- doxycycline monohydrate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Gardner
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dark Adaptation, Rod Intercept |
0.3; -0.3 | .70 |
| PRIMARY Change in Photopic Visual Field |
-0.8; -0.8; -0.74; -1.0 | .33 |
| PRIMARY Change in Frequency Doubling Perimetry (FDP) |
-1.9; 1.8; -0.7; 0.7 | .02 sig |
| PRIMARY Change in Early Treatment Diabetic Retinopathy Study (ETDRS) |
0.3; 0.2 | .98 |
| SECONDARY Change in Central Subfield Thickness |
-1.5; 4.8 | .46 |
| SECONDARY Change in Macular Volume |
-0.2; -0.1 | .81 |
| SECONDARY Change in Central Retinal Artery Equivalent (CRAE) Diameter |
-0.49; 0.17 | .88 |
| SECONDARY Change in Central Retinal Vein Equivalent (CRVE) Diameter |
-6.3; -6.6 | .75 |
| SECONDARY Change in Arteriovenous Ratio Diameter |
0.013; 0.013 | .62 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- age ≥ 18 years old
- diagnosis of type 1 or type 2 diabetes mellitus
- have a hemoglobin A1c less than 11% at pre-qualification visit
- able and willing to give informed consent
- best-corrected ETDRS visual acuity in study eye ≥ 49 letters (20/100)
- severe non-proliferative diabetic retinopathy (ETDRS level 53E) or retinal and/or optic disk neovascularization less than the "high-risk" characteristics defined by the Diabetic Retinopathy Study (ETDRS level61- 65), and in whom panretinal photocoagulation is not imminently required in the ophthalmologist's judgment
- able to perform reliable visual field and dark adaptation testing
- central subfield thickness on OCT of ≤ 275microns
- foveal fixation present in each eye (assessed by fundus photography using an internal fixation pointer or assessed by the investigator)
- media clarity and pupil dilation sufficient for high-quality fundus photographs and fluorescein angiograms
Exclusion Criteria
- high-risk neovascularization in study eye
- prior panretinal photocoagulation in the study eye
- focal/grid laser photocoagulation in the macula within the past 15 weeks in the study eye
- intraocular pressure > 22mmHg by Goldmann Tonometry in the study eye
- history of pars plana vitrectomy in the study eye
- vitreous or pre-retinal hemorrhage 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 24 months
- 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
Data sourced from ClinicalTrials.gov (NCT00511875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.