Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

— DRAGONS  

Official title:

Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05333055
• Other study ID #: DRAGONS
• Status: Not yet recruiting
• Start date: April 11, 2022
• Est. completion date: August 2023

Study information

• Verified date: April 2022
• Source: Greater Houston Retina Research
• Contact: Cassandra Cone
• Phone: 713-394-7537
• Email: cassandra.cone[@]retinaconsultantstexas.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Greater Houston Retina Research

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of Biomarkers	The correlation of aqueous humor disease state biomarker levels with plasma/serum disease state biomarker levels as well as clinical images including optical coherence tomography images (OCT), OCT-angiograms, fluorescein angiograms, and fundus photographs.	Baseline
Primary	Aqueous Humor Levels of VEGF-A		Baseline
Primary	Aqueous Humor Levels of Plasma Kallikrein	Total Kallikrein (KLKB1), Active Kallikrein (pKal), Factor Xlla	Baseline
Primary	Aqueous Humor Levels of Angiopoietin-2		Baseline
Secondary	Aqueous Humor Levels of Additional Disease State Biomarkers	Angiopoietin-1, VEGF-D, IP-10, MCP-1, placental growth factor, platelet derived growth factor-B, TGF-ß2, IL-1ß, IL-6, IL-8, ICAM-1.	Baseline

External Links

•   2016 Global Report on Diabetes