Ketorolac Eye Drops for Diabetic Retinopathy (INSPIRE Trial)

Palo Alto (17 mi)

Overseen byStephen J Kim, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Stephen J. Kim, MD

Trial Summary

What is the purpose of this trial?This trial tests if regular use of ketorolac eye drops can reduce inflammation and slow down or prevent the worsening of Diabetic Retinopathy in adults with type II diabetes. Ketorolac has been shown to be effective in reducing inflammation and symptoms associated with eye allergies and after surgery.

Eligibility Criteria

This trial is for adults with type II diabetes and moderate Diabetic Retinopathy (DR), specifically those with an HbA1c ≥ 8. It's also for age-matched non-diabetics needing vitrectomy surgery without inflammation. Excluded are individuals with ocular trauma, certain eye conditions, high blood pressure, or using NSAIDs regularly.

Inclusion Criteria

I am an adult with type II diabetes.

I am 18 or older with type II diabetes, moderate NPDR, and HbA1c ≥ 8.

Exclusion Criteria

I have a disease affecting the macula, blood vessels in the eye, or eye inflammation.

I regularly use NSAIDs or aspirin.

I have diabetes and have had a vitrectomy in at least one eye.

I have had a vitrectomy in one or both of my eyes.

I regularly use NSAIDs or aspirin for my diabetes.

I have had an eye injury in the past.

I have diabetes and have had an eye injury.

I have diabetes and also a disease affecting my eye's macula, blood vessels, or causing inflammation.

Treatment Details

The study tests if topical ketorolac eye drops can reduce inflammatory mediators in the eyes of diabetic patients and slow DR progression compared to placebo (artificial tears). Measurements of PGE2 and cytokines in the aqueous part of the eye will help assess this.

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Age-matched Non-diabeticsExperimental Treatment1 Intervention

We will also enroll 100 age-matched patients without diabetes who are undergoing unilateral vitrectomy surgery for non-inflammatory conditions such as epiretinal membrane or macular hole. Removed aqueous fluid that is typically discarded will instead be collected and stored at -80° C. Aqueous fluid will be tested for inflammatory markers as detailed below to provide a reference level for cross-comparison analysis.

Group II: Adult Type II Diabetics - No Diabetic Retinopathy (DR)Experimental Treatment1 Intervention

23 Adult type II diabetic patients with no diabetic retinopathy as a control group.

Group III: Adult Type II Diabetics - Moderate NPDR - KetorolacExperimental Treatment2 Interventions

59 Adult type II diabetic patients with baseline moderate non-proliferative diabetic retinopathy and HbA1c ≥ 8 randomized to Ketorolac treatment.

Group IV: Adult Type 2 Diabetics-Proliferative Diabetic Retinopathy(PDR)Experimental Treatment1 Intervention

23 Adult type II diabetic patients with proliferative diabetic retinopathy as a control group.

Group V: Adult Type II Diabetics - Moderate NPDR - PlaceboPlacebo Group2 Interventions

59 Adult type II diabetic patients with baseline moderate non-proliferative diabetic retinopathy randomized to placebo treatment.