Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or … (NCT00511875) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy
United States30 participantsStarted 2008-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
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
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Dark Adaptation, Rod Intercept
Timeframe: Baseline and 24 months
2
Change in Photopic Visual Field
Timeframe: Baseline and 24 months
3
Change in Frequency Doubling Perimetry (FDP)
Timeframe: 24 months
4
Change in Early Treatment Diabetic Retinopathy Study (ETDRS)