Key result
Topical ketorolac shows balanced baseline characteristics versus placebo in the INSPIRE study evaluating inflammatory cytokines.
Why the study?
The study was conducted to evaluate inflammatory intraocular and systemic cytokines associated with diabetic retinopathy and diabetic macular edema.
Does topical ketorolac 0.45% alter inflammatory cytokine and prostaglandin levels in adult patients with moderate nonproliferative diabetic retinopathy?
RCT (n=271)
double-masked
randomized
Does topical ketorolac 0.45% alter inflammatory cytokine and prostaglandin levels in adult patients with moderate nonproliferative diabetic retinopathy?
The INSPIRE study aims to characterize the role of inflammatory mediators in diabetic retinopathy and evaluate the effect of topical ketorolac on these biomarkers.
Baseline balance aids valid inference; leaves open ketorolac efficacy in ocular conditions pending INSPIRE outcomes.
Purpose: To evaluate inflammatory intraocular and systemic cytokines associated with diabetic retinopathy (DR) and diabetic macular edema (DME). Methods: The INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy (INSPIRE) study is a prospective, placebo-controlled, interventional study that enrolled 328 eyes of 164 adult patients with type II diabetes. 118 (236 eyes) diabetic patients with moderate nonproliferative diabetic retinopathy (NPDR) were randomized to either topical ketorolac 0.45% (Acuvail®) or placebo (Refresh Optive ®, preservative free) in double-masked fashion. A cohort of 23 (46 eyes) patients with diabetes but no retinopathy (No DR) and 23 patients with proliferative diabetic retinopathy (PDR) were also enrolled. All patients underwent complete ophthalmic examination including bilateral aqueous biopsies to test for 24 inflammatory cytokines and 5 classes of prostaglandins. A group of 107 patients without diabetes who were undergoing elective vitrectomy for non-inflammatory conditions had blood and aqueous fluid collected at the time for surgery for cross-comparison analysis. Results: There was similar age and sex distribution across cohorts. The study population was predominantly white. Longer duration of diabetes was observed in the NPDR and PDR groups. The ocular characteristics of all patients were similar for visual acuity, IOP, lens status and median central subfield thickness. Discussion: The INSPIRE study may provide greater understanding of the role of inflammation in DR and allow for the discovery of novel biomarkers and therapeutic targets that can better predict risk of vision loss and prevent progression of DR and DME.
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Gangaputra et al. (2025) conducted an RCT in Diabetic retinopathy and diabetic macular edema (n=271). Topical ketorolac vs. Placebo was evaluated on Inflammatory intraocular and systemic cytokines. Topical ketorolac 0.45% versus placebo is being evaluated in the INSPIRE study, which enrolled 271 patients and demonstrated similar baseline age, sex, and ocular characteristics across cohorts.
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