Objective To investigate the adverse ocular effects of intravitreal ketorolac (4 mg) in patients with chronic uveitis and complications of chronic inflammation (macular edema).
Methods We conducted a prospective phase 1 clinical trial involving 10 eyes of 10 adult patients with chronic inflammation and/or macular edema for whom previous treatment failed or who could not tolerate corticosteroids because of adverse ocular effects. Baseline (day 0) electroretinography, fluorescein angiogram, spectral domain optical coherence tomography (OCT), Goldmann visual field, and complete ophthalmic examination were performed, and then a single intravitreal injection of ketorolac (4 mg) was administered. Another ophthalmic examination with OCT was performed on day 3. Ophthalmic examination with fluorescein angiogram and OCT was repeated on days 7 and 30, and ophthalmic examination with fluorescein angiogram, OCT, electroretinography, and Goldmann visual field was performed on day 90. The study took place from March 1, 2010, through February 28, 2011.
Results On the basis of ophthalmic examination findings, visual field, and electroretinography testing, there were no observed adverse ocular effects of intravitreal ketorolac. In 2 of 2 eyes with active intraocular inflammation, there was early resolution of inflammation, and in 4 of 8 eyes with macular edema, there appeared to be transient reduction in OCT thickness and/or fluorescein angiogram leakage.
Conclusion A single intravitreal injection of ketorolac (4 mg) appeared to be well tolerated.
Clinical Relevance Intravitreal ketorolac requires further clinical trials to determine whether it is an effective means to treat posterior segment inflammation as a safer alternative to corticosteroids in patients at increased risk of cataract formation and increased intraocular pressure.
Trial Registration clinicaltrials.gov Identifier: NCT01164085