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Nonsteroidal Anti-inflammatory Drug

Ketorolac Eye Drops for Diabetic Retinopathy (INSPIRE Trial)

Phase 1

Waitlist Available

Led By Stephen J Kim, MD

Research Sponsored by Stephen J. Kim, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aim 1 Diabetic Arm: Adult patients age 18 years or greater with type II diabetes

Aim 2: Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and HbA1c ≥ 8

Must not have

Aim 2: Co-existent macular, retinovascular, or inflammatory disease

Aim 2: 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Ketorolac may cause side effects like eye irritation, discomfort or redness, headaches, increased bleeding tendency during surgery, and potential corneal problems in predisposed individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult with type II diabetes.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I regularly use NSAIDs or aspirin.

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

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

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I regularly use NSAIDs or aspirin for my diabetes.

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I have had an eye injury in the past.

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I have diabetes and have had an eye injury.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interleukin 6 (IL-6) level during Diabetic Retinopathy progression

Interleukin 8 (IL-8) level during Diabetic Retinopathy progression

PGE2 level during Diabetic Retinopathy progression

+3 more

Secondary study objectives

Incidence of Diabetic Macular Edema

Progression of Diabetic Macular Edema

Trial Design

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.

0 / 10Eligibility criteria met