Study 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.
Eligible Conditions
- Diabetic Retinopathy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 2 Secondary · Reporting Duration: 3 years
1 year
Interleukin 6 (IL-6) level during Diabetic Retinopathy progression
Interleukin 8 (IL-8) level during Diabetic Retinopathy progression
PGE2 level during Diabetic Retinopathy progression
Vascular Endothelial Growth Factor (VEGF) level during Diabetic Retinopathy progression
3 years
Incidence of Diabetic Macular Edema
Progression of Diabetic Macular Edema
Progression of Diabetic Retinopathy (DR)
Diabetic Retinopathy
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Adult Type II Diabetics - Moderate NPDR - Ketorolac
1 of 2
Adult Type II Diabetics - Moderate NPDR - Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
264 Total Participants · 2 Treatment Groups
Primary Treatment: Aqueous PGE2 and inflammatory cytokines measurements · Has Placebo Group · Phase 1
Adult Type II Diabetics - Moderate NPDR - KetorolacExperimental Group · 2 Interventions: Aqueous PGE2 and inflammatory cytokines measurements, Ketorolac 0.45% ophthalmic solution · Intervention Types: Other, Drug
Adult Type II Diabetics - Moderate NPDR - PlaceboPlaceboComparator Group · 2 Interventions: Placebo - Preservative-free artificial tears, Aqueous PGE2 and inflammatory cytokines measurements · Intervention Types: Drug, Other
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Who is running the clinical trial?
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,109 Total Patients Enrolled
7 Trials studying Diabetic Retinopathy
1,457 Patients Enrolled for Diabetic Retinopathy
Stephen J. Kim, MDLead Sponsor
National Eye Institute (NEI)NIH
517 Previous Clinical Trials
1,072,632 Total Patients Enrolled
46 Trials studying Diabetic Retinopathy
39,354 Patients Enrolled for Diabetic Retinopathy
Stephen J Kim, MDPrincipal InvestigatorVanderbilt University Medical Center
7 Previous Clinical Trials
215 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients with type II diabetes and moderate NPDR and HbA1c ≥ 8.
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Conditions
Cancer Related
Treatments