Ketorolac Eye Drops for Diabetic Retinopathy
(INSPIRE Trial)
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.
Will I have to stop taking my current medications?
If you are currently using prescription systemic NSAIDs or regularly using nonprescription NSAIDs like aspirin, you will need to stop taking them to participate in this trial.
What data supports the effectiveness of the drug Ketorolac 0.45% ophthalmic solution for diabetic retinopathy?
Ketorolac 0.45% eye drops have been shown to reduce inflammation and pain after cataract surgery, and they may help improve visual function in diabetic patients with macular edema (swelling in the eye) after certain treatments. This suggests that Ketorolac could potentially help with inflammation and visual outcomes in diabetic retinopathy.12345
Is ketorolac 0.45% ophthalmic solution safe for use in humans?
How does the drug Ketorolac 0.45% ophthalmic solution differ from other treatments for diabetic retinopathy?
Ketorolac 0.45% ophthalmic solution is unique because it is a non-steroidal anti-inflammatory drug (NSAID) administered as eye drops, offering a topical treatment option for diabetic retinopathy. This differs from traditional treatments like laser photocoagulation, which can be invasive and uncomfortable, and systemic drugs that affect the entire body.89101112
Research Team
Stephen J Kim, MD
Principal Investigator
Vanderbilt University Medical Center
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily topical application of ketorolac or placebo to study its effects on PGE2 and cytokine levels, and DR progression
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression of DR and DME
Treatment Details
Interventions
- Ketorolac 0.45% ophthalmic solution
- Placebo - Preservative-free artificial tears
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stephen J. Kim, MD
Lead Sponsor
Allergan
Industry Sponsor
Brent Saunders
Allergan
Chief Executive Officer since 2015
JD and MBA from Temple University
Dr. David Nicholson
Allergan
Chief Medical Officer since 2015
MD from Harvard Medical School
National Eye Institute (NEI)
Collaborator