NCT05333055Terminated
Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
Source: ClinicalTrials.gov · Last updated 24 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 107 (actual)
- First submitted
- 11 Apr 2022
- Start date
- 10 Feb 2022
- Primary completion date
- 15 May 2024
- Lead sponsor
- Greater Houston Retina Research
- Diseases
- Diabetic eye disease
- NCT number
- NCT05333055
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- Systemic anti-VEGF treatment within 90 days of signing informed consent
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Consultants of Texas | Bellaire | United States | Unknown status |
| Retina Consultants of Texas | Katy | United States | Unknown status |
| Retina Consultants of Texas | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.