MedTrace Logo

Sirolimus as Therapeutic Approach to Uveitis

NCT00908466 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Uveitis
  • Intermediate Uveitis
  • Posterior Uveitis
  • Panuveitis

Interventions

DRUG

Sirolimus (rapamycin)

Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.

DRUG

Sirolimus (rapamycin)

Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.

Sponsors & Collaborators

Principal Investigators

  • Quan D Nguyen, MD, MSc · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-07-31
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00908466 on ClinicalTrials.gov