DRAGONS: Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema

Sponsor
Greater Houston Retina Research (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05333055
Collaborator
(none)
150
15.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
    Anticipated Study Start Date :
    Apr 11, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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 is anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole

    Outcome Measures

    Primary Outcome Measures

    1. Aqueous Humor Levels of VEGF-A [Baseline]

    2. Aqueous Humor Levels of Plasma Kallikrein [Baseline]

      Total Kallikrein (KLKB1), Active Kallikrein (pKal), Factor Xlla

    3. Aqueous Humor Levels of Angiopoietin-2 [Baseline]

    Secondary Outcome Measures

    1. Aqueous Humor Levels of Additional Disease State Biomarkers [Baseline]

      Angiopoietin-1, VEGF-D, IP-10, MCP-1, placental growth factor, platelet derived growth factor-B, TGF-β2, IL-1β, IL-6, IL-8, ICAM-1.

    Other Outcome Measures

    1. Correlation of Biomarkers [Baseline]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Greater Houston Retina Research

    Investigators

    • Principal Investigator: Charles C. Wykoff, MD, PhD, Greater Houston Retina Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Greater Houston Retina Research
    ClinicalTrials.gov Identifier:
    NCT05333055
    Other Study ID Numbers:
    • DRAGONS
    First Posted:
    Apr 18, 2022
    Last Update Posted:
    Apr 18, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2022