Phase 2
Completed N=33
Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy
Source: ClinicalTrials.gov NCT00917553 ↗Enrolled (actual)
33
Serious AEs
36.4%
Results posted
Nov 2018
Primary outcomePrimary: The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group — 2.80; 0.13 dB
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group |
2.80; 0.13 | — |
| SECONDARY Change Thickness Thickness |
17.5; 21.3; 25.6; 26.1 | — |
| SECONDARY Change in Macular Volume |
0.06; 0.23 | — |
| SECONDARY Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level |
0; 1; 9; 7; 0; 2 | — |
| SECONDARY Number of Participants Who Developed Vitreous or Preretinal Hemorrhage |
0; 0 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00917553). 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. Informational only — not medical advice.