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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: Active Phase 1 study of Diabetic Retinopathy, sponsored by Stephen J. Kim, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Aqueous samples will be analyzed using liquid chromatography electrospray ionization tandem mass spectrometry to measure all PGE2 levels. PGE2 will be measured every 4 months during 1 year of study to determine whether their mean mediator levels associate with DR severity stage using a linear mixed effects model. The DR severity stage will be included as a continuous or categorical variable, and potential confounding factors as well as baseline measurements for each inflammatory mediator, will b
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 |
What the registry record for NCT04505566 still lists
NCT04505566 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Where NCT04505566's enrollment target sits among peer trials
164 32nd of 57 higher than 26 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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