At a glance
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A Phase 1, Open-label, Randomized Clinical Study to Assess the Safety, Tolerability and Bioactivity of Intravitreal and Subconjunctival Injection of Sirolimus in Patients With Non-infectious Uveitis
In Brief
A Phase 1 clinical trial evaluating Sirolimus (rapamycin) for Uveitis and 3 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study is to find out about the safety and effectiveness of the study drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of sirolimus, and yet to avoid the potential complications of systemic use of the drug. In this study, the investigators will administer sirolimus either around (subconjunctival injection) or inside the eye (intravitreal injection). Local administration of sirolimus to the eye is not expected to have effects on the rest of the body. Therefore, it may offer a safer way than the current methods used to control the inflammation caused by non-infectious uveitis.
Study Details
Timeline
Interventions
Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.
Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.