NCT00876434

Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing Sirolimus in Anterior Uveitis in 5 participants. Completed in 10 February 2011.

Timeline

1 April 2009

Primary endpoint
10 February 2011

10 February 2011

Quick facts

Lead sponsor	National Eye Institute (NEI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 April 2009
Primary completion	10 February 2011
Estimated completion	10 February 2011
Sites	1 location across United States

Drugs / interventions tested

• Sirolimus (sirolimus) — full drug profile →

Conditions studied

• Anterior Uveitis — all drugs for Anterior Uveitis →

Sponsor

National Eye Institute (NEI)

Who can join

18 and older, any sex, with Anterior Uveitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Uveitis is an inflammatory condition in which the patient's own immune system attacks the eye, causing eye inflammation and vision loss. Patients with uveitis may be treated with immunosuppressive medications to reduce the inflammation and prevent vision loss.
* Sirolimus is an immunosuppressive medication that is approved by the U.S. Food and Drug Administration (FDA) to prevent organ rejection following a kidney transplant. Researchers think that sirolimus may affect the part of the immune system that may be an important cause of uveitis, and may decrease the inflammation that causes uveitis.
* In this study, sirolimus will be given as an injection under the outer layer of your eye. The FDA has permitted the investigational use of sirolimus for this study.

Objectives:

* To determine if subconjunctival injection of sirolimus is safe for treatment of uveitis.
* To see if sirolimus is an effective treatment for uveitis.

Eligibility:

* Patients 18 years of age and older with active uveitis in one or both eyes. If a patient has uveitis in both eyes, the one in which the inflammation is worse will be treated during the study. The vision in the study eye must be at least 20/400.
* Patients must have good liver function, and must be willing to practice sun protection measures for 2 weeks following the treatment.

Design:

* Treatment with sirolimus in the study eye:
* Antibiotic and numbing eye drops will be given before the sirolimus injection.
* 1 dose of sirolimus will be injected directly into the subconjunctiva (white part of the eye).
* Antibiotic drops will be given for topical application 3 times per day for 2 days after the injection.
* Patients will be followed for 16 weeks after sirolimus injection (initial visit and follow-up visits in Weeks 2, 4, 8, 12, and 16).
* Evaluations during the treatment period and follow-up visits:
* Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
* Full medical and ophthalmic history, involving questionnaires and discussion with researchers.
* Eye examination, dilation, and photography, including measurements of retinal thickness and fluorescent dye tests of blood flow in the eye.
* Blood and urine tests.
* Because of the increased risk of skin cancer associated with sirolimus, patients ...

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advanced drug delivery and targeting technologies for the ocular diseases.
   Barar J, Aghanejad A, Fathi M, Omidi Y. · · 2016 · cited 92× · PMID 27340624 · DOI 10.15171/bi.2016.07
2. Low dose rapamycin exacerbates autoimmune experimental uveitis.
   Zhang Z, Wu X, Duan J, Hinrichs D, et al · · 2012 · cited 25× · PMID 22574188 · DOI 10.1371/journal.pone.0036589
3. Subconjunctival sirolimus for the treatment of chronic active anterior uveitis: results of a pilot trial.
   Sen HN, Larson TA, Meleth AD, Smith WM, et al · · 2012 · cited 21× · PMID 22465364 · DOI 10.1016/j.ajo.2011.12.018
4. Ocular immune-related diseases: molecular mechanisms and therapy.
   Wang Y, Gao S, Cao F, Yang H, et al · · 2024 · cited 10× · PMID 39611043 · DOI 10.1002/mco2.70021