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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
INSPIRE Trial Summary
This trial is testing whether or not the drug ketorolac can help to treat and prevent the progression of Diabetic Retinopathy, by reducing the levels of inflammatory mediators in the eye.
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.Check my eligibility
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.See study design
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.
INSPIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with type II diabetes.
Select...
I am 18 or older with type II diabetes, moderate NPDR, and HbA1c ≥ 8.
INSPIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Incidence of Diabetic Macular Edema
Progression of Diabetic Macular Edema
INSPIRE 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.
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Who is running the clinical trial?
Stephen J. Kim, MDLead Sponsor
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,305 Total Patients Enrolled
7 Trials studying Diabetic Retinopathy
1,457 Patients Enrolled for Diabetic Retinopathy
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,664 Total Patients Enrolled
50 Trials studying Diabetic Retinopathy
42,681 Patients Enrolled for Diabetic Retinopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a disease affecting the macula, blood vessels in the eye, or eye inflammation.I am an adult with type II diabetes.I regularly use NSAIDs or aspirin.I am 18 or older with type II diabetes, moderate NPDR, and HbA1c ≥ 8.I have diabetes and have had a vitrectomy in at least one eye.I am of similar age, don't have diabetes, and need surgery for a non-inflammatory eye condition.I have had a vitrectomy in one or both of my eyes.I regularly use NSAIDs or aspirin for my diabetes.I have not had an eye injection in the last 3 months.You have an artificial lens in the front part of your eye.I am diabetic and at risk for corneal melting.Your blood pressure is higher than 180 over 110.You have an artificial lens in the front part of your eye.I have had an eye injury in the past.Participants with diabetes who have had their natural eye lenses removed.Participants without a natural lens in the eye.Your blood pressure is higher than 180 over 110.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.Risk of the cornea melting.I have diabetes and received an eye injection in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Adult Type II Diabetics - Moderate NPDR - Placebo
- Group 2: Adult Type II Diabetics - Moderate NPDR - Ketorolac
- Group 3: Adult Type 2 Diabetics-Proliferative Diabetic Retinopathy(PDR)
- Group 4: Age-matched Non-diabetics
- Group 5: Adult Type II Diabetics - No Diabetic Retinopathy (DR)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA endorse measuring Aqueous PGE2 and inflammatory cytokines?
"Due to the limited clinical data on Aqueous PGE2 and inflammatory cytokines measurements, our team at Power assigned a rating of 1 out of 3 for safety."
Answered by AI
How many participants are currently accepted in this scientific experiment?
"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting participants starting from 11th of September 2020 and was last updated on 16th February 2022; a total of 264 patients are being sought after at one medical centre."
Answered by AI
Are there still opportunities to enroll in this scientific trial?
"Clinicaltrials.gov records indicate that this medical investigation is actively enrolling patients. It was initially published on November 9th 2020, and the most recent edit occurred February 16th 2022."
Answered by AI
How is the assessment of Aqueous PGE2 and inflammatory cytokines typically applied for therapeutic purposes?
"Aqueous PGE2 and inflammatory cytokines measurements are frequently employed as a method to reduce ocular irritation. It is also known for its efficacy in managing pain, inducing nerve blockage, and altering pupil size."
Answered by AI
What research has been done to determine the correlation between Aqueous PGE2 and inflammatory cytokines?
"Presently, 38 trials of Aqueous PGE2 and inflammatory cytokines measurements have been launched. 8 of them are in the last stage of research - Phase 3. The primary hub for these studies is Los Angeles, California; yet there are 57 total sites running related experiments."
Answered by AI
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