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Intravitreal Sirolimus as Therapeutic Approach to Uveitis

NCT01280669 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-10-26

No results posted yet for this study

Summary

The purpose of this study is to find out about the safety and effectiveness of two different doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and yet avoid the potential complications that are usually associated with the systemic use of the drug and other immunomodulatory therapies. In this study, the investigators will administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or 880mcg/mcL). 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.

Conditions

  • Uveitis
  • Intermediate Uveitis
  • Posterior Uveitis
  • Panuveitis

Interventions

DRUG

Intravitreal injection 440mcg

Intravitreal injections of sirolimus 440mcg/20mcL at baseline and months 1, 2, 3, 4, and 5.

DRUG

Intravitreal injection of sirolimus 880mcg

Intravitreal injection of 880mcg/20mcL sirolimus at baseline and months 2 and 4.

Sponsors & Collaborators

Principal Investigators

  • Quan D Nguyen, MD, MSc · Stanford University Byers Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-09-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280669 on ClinicalTrials.gov