Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04505566 · ClinicalTrials.gov registry record · Phase 1
INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study
A Phase 1 study of Diabetic Retinopathy, sponsored by Stephen J. Kim, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 164
- Enrollment target
- 1
- Study location
NCT04505566 is a Phase 1 study of Diabetic Retinopathy that is active but no longer recruiting, run by Stephen J. Kim, MD. The registered enrollment target is 164 participants, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04505566, a Phase 1 study of Diabetic Retinopathy, is active but no longer recruiting, sponsored by Stephen J. Kim, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 164 participants
- Enrollment target
- 1
- Study location
Study Summary
The central hypothesis is that inflammation mediators are biomarkers of both systemic diabetes and Diabetic Retinopathy (DR) progression in the aqueous and that sustained topical ketorolac application reduces/suppresses those inflammatory mediators thereby reducing the progression of Diabetic Retinopathy.
Conditions Studied
Interventions
- DRUG Ketorolac 0.45% ophthalmic solution
- DRUG Placebo - Preservative-free artificial tears
- OTHER Aqueous PGE2 and inflammatory cytokines measurements
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04505566
The ClinicalTrials.gov registry entry for NCT04505566 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (90% lower). The listed sponsor is Stephen J. Kim, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 3 interventions - of which Ketorolac 0.45% ophthalmic solution is the first listed.
NCT04505566 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04505566 about?
NCT04505566 is a clinical study titled "INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study". The central hypothesis is that inflammation mediators are biomarkers of both systemic diabetes and Diabetic Retinopathy (DR) progression in the aqueous and that sustained topical ketorolac application reduces/suppresses those inflammatory mediators thereby reducing the progression of Diabetic Retino...
What is the current status of trial NCT04505566?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 164 participants. The study started on 2020-11-09. Estimated completion is 2026-05.
What conditions does trial NCT04505566 study?
This clinical trial studies the following conditions: Diabetic Retinopathy.
What interventions are being tested in trial NCT04505566?
The interventions under investigation include: Ketorolac 0.45% ophthalmic solution (DRUG), Placebo - Preservative-free artificial tears (DRUG), Aqueous PGE2 and inflammatory cytokines measurements (OTHER).
Who is sponsoring clinical trial NCT04505566?
This trial is sponsored by Stephen J. Kim, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04505566 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Retinopathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
ACTIVE NOT RECRUITING · Phase 1
-
A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)
COMPLETED · Phase 1
-
Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders
COMPLETED · Phase 1
-
A Phase 1 Safety Study of TG100801 Eye Drops in Healthy Volunteers
COMPLETED · Phase 1
-
A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
COMPLETED · Phase 1
-
Fenofibrate for Prevention of DR Worsening
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.