Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
Stopped early
Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema, Other Retinal Disorders
In brief
The DRAGONS study is a non-interventional, prospective study that will 1. characterize disease state biomarker (including cytokines, KKS metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (DR) and diabetic macular edema (DME) as well as other retinal pathologies, and 2. correlate a broad array of aqueous humor disease state biomarkers with DR severity, DME anti-vascular endothelial growth factor (VEGF) responsiveness, and other retinal pathologies.
Key facts
- Study ID
- NCT05333055
- Run by
- Greater Houston Retina Research
- People needed
- 107
- Starts
- 2022-02-10
- Expected to finish
- 2024-05-15
- Last updated by the study team
- 2025-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with at least one of the following retinal conditions in at least one eye:
- Treatment naive diabetic retinopathy (group 1 only);
- Diabetic retinopathy with DME that is incompletely responsive to anti-VEGF therapy at principal investigators discretion with retinal thickening documented on OCT (group 2 only);
- Various retinal disease including but not limited to diabetic retinopathy without DME which has previously been treated, DME which has responded to anti-VEGF therapy, neovascular age-related macular degeneration, branch or central retinal vein occlusions, epiretinal membrane, or macular hole (group 3 only)
You may not qualify if…
- Prior intraocular or subtenon steroid injection in the study eye within the prior 1 year of signing informed consent;
- Prior focal or grid laser photocoagulation in the study eye if within 90 days of signing informed consent;
- Prior panretinal photocoagulation in the study eye if within 90 days of signing informed consent;
- Intraocular or refractive surgery in the study eye within 90 days of signing informed consent;
- Systemic anti-VEGF treatment within 90 days of signing informed consent
Where it is running
- Retina Consultants of Texas — Bellaire, Texas, United States
- Retina Consultants of Texas — Katy, Texas, United States
- Retina Consultants of Texas — The Woodlands, Texas, United States
Full record on ClinicalTrials.gov
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