Clinical trial NCT05333055: Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
Official title: Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Other Retinal Disorders
Lead sponsor: Greater Houston Retina Research
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retina Consultants of Texas patient population

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 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.

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 study if at least one eye meets any of the following criteria:

Group 1 - eyes with treatment naive DR with or without DME Group 2 - eyes with DME that are incompletely responsive to anti-VEGF therapy Group 3 - eyes with various retinal conditions including eyes with DR and DME that are anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole

The study will consist of a single visit and a retrospective chart review. The study visit will consist of:

1. Screening for eligibility;
2. Aqueous humor collection;
3. Blood collection;
4. Optical coherence tomography;
5. Optical coherence tomography angiography;
6. Fundus photography; and
7. Fluorescein angiography.

Approximately 50 microliters (or more, up to 150 microliters) of aqueous fluid will be collected according to standard clinical procedures. Plasma and serum will be collected according to standard clinical procedures, with citrated plasma being specifically collected in a plastic tube.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

1. Prior intraocular or subtenon steroid injection in the study eye within the prior 1 year of signing informed consent;
2. Prior focal or grid laser photocoagulation in the study eye if within 90 days of signing informed consent;
3. Prior panretinal photocoagulation in the study eye if within 90 days of signing informed consent;
4. Intraocular or refractive surgery in the study eye within 90 days of signing informed consent;
5. Systemic anti-VEGF treatment within 90 days of signing informed consent

Primary outcomes:
measure: Aqueous Humor Levels of Disease State Biomarkers
timeFrame: Baseline
Secondary outcomes:
measure: Correlation of Biomarker Levels
timeFrame: Baseline
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
affiliation: Greater Houston Retina Research
name: Charles C. Wykoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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