Status:
TERMINATED
Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
Lead Sponsor:
Greater Houston Retina Research
Conditions:
Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
The DRAGONS study is a non-interventional study investigating aqueous humor biomarker levels in patients with various stages of DR, DME and other retinal pathologies. Subjects will be included in the...
Eligibility Criteria
Inclusion
- 1\. 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT05333055
Start Date
February 10 2022
End Date
May 15 2024
Last Update
January 24 2025
Active Locations (3)
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1
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
2
Retina Consultants of Texas
Katy, Texas, United States, 77494
3
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384