NCT04505566CompletedPhase 1
INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study
INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy (INSPIRE) Study
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 164 (actual)
- First submitted
- 31 Jul 2020
- Start date
- 9 Nov 2020
- Primary completion date
- 21 Apr 2026
- Lead sponsor
- Stephen J. Kim, MD
- Diseases
- Diabetic eye disease
- NCT number
- NCT04505566
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 164
- From 9 Nov 2020 to the primary completion date, 21 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Aim 1 Diabetic Arm Exclusion Criteria: Patients with a history of previous vitrectomy in either eye; prior intravitreal injection within 3 months; co-existent macular, retinovascular, or inflammatory disease; history of ocular trauma; aphakia; presence of an anterior chamber intraocular lens; current use of prescription systemic NSAIDs or regular use of nonprescription NSAIDs including aspirin (defined as 4 days or more a week for at least 2 weeks a month); blood pressure \> 180/110 mmHg; risk for corneal melting; and inability to comply with follow-up.
- Aim 2 Exclusion Criteria: Patients with a history of previous vitrectomy in either eye; prior intravitreal injection within 3 months; co-existent macular, retinovascular, or inflammatory disease; history of ocular trauma; aphakia; presence of an anterior chamber intraocular lens; current use of prescription systemic NSAIDs or regular use of nonprescription NSAIDs including aspirin (defined as 4 days or more a week for at least 2 weeks a month); blood pressure \> 180/110 mmHg; risk for corneal melting; and inability to comply with follow-up.
Other
- Aim 1 Nondiabetic Control Arm Exclusion Criteria: Patients who are unable to comply with testing and follow-up.
Who the study is looking for
- Aim 1 Diabetic Arm Inclusion Criteria: Adult patients age 18 years or greater with type II diabetes.
- Aim 1 Nondiabetic Control Arm Inclusion Criteria: age-matched patients without diabetes who are undergoing unilateral vitrectomy surgery for non-inflammatory conditions such as epiretinal membrane or macular hole.
- Aim 2 Inclusion Criteria: Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and HbA1c ≥ 8.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
Related publications
- INFLAMMATORY MEDIATORS IN DIABETIC MACULAR EDEMA: A Prospective, Controlled Study.Retina · 2026 · PMID 42246764
This page is information, not medical advice. Discuss any trial with your doctor.