Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 9:06 AM
Study NCT ID:
NCT00876434
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2009-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveitis
Status:
COMPLETED
Status Verified Date:
2011-02-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ...
* 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 ...
Detailed Description:
Objective: Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse effects and many patients continue to experience disease flare-ups. Sirolimus suppresses cytokine-driven T-cell proliferation and thus, inhibits the production, signaling and activity of many growth factors relevant to uveitis. Subconjunctival sirolimus administration could reduce or eliminate the need for topical and/or systemic immunosuppressive drugs that could result in reduced morbidity. This protocol will investigate subconjunctival sirolimus as a possible treatment for active anterior uveitis.
Study Population: Five participants with active anterior uveitis will be initially accrued in this study. Participants must require treatment for their uveitis with systemic and/or topical anti-inflammatory medications at high frequency intervals \[greater than or equal to three times daily (T.I.D.)\] or local steroid treatment (periocular steroid injections) is contraindicated because of significant intraocular pressure (IOP) elevation with local steroid treatments in the past (i.e., steroid responder), have at least a grade of 1+ for anterior chamber cells and have visual acuity of at least 20/400 in the study eye. Up to seven participants may be enrolled, as up to two participants may be accrued to replace enrolled participants who withdraw from the study prior to receiving any study medication.
Design: This is a Phase I, non-randomized, prospective, uncontrolled single-center study to evaluate subconjunctival sirolimus as a treatment for active anterior uveitis. All participants will receive a single 30-microL (1,320 microg) subconjunctival sirolimus injection in the study eye at baseline and will be followed for 16 weeks post-injection.
Outcome Measures: The primary outcome is the number of participants who experience at least a 2-step reduction in anterior chamber inflammation within four weeks post-injection. Secondary outcomes include changes in visual acuity and anterior chamber inflammation grading, the number of participants who experience a disease flare within the 16-week study duration and, of the participants who experience a disease flare, the number of days to disease flare from baseline. Secondary outcomes also include the presence or extent of cystoid macular edema.
Study Population: Five participants with active anterior uveitis will be initially accrued in this study. Participants must require treatment for their uveitis with systemic and/or topical anti-inflammatory medications at high frequency intervals \[greater than or equal to three times daily (T.I.D.)\] or local steroid treatment (periocular steroid injections) is contraindicated because of significant intraocular pressure (IOP) elevation with local steroid treatments in the past (i.e., steroid responder), have at least a grade of 1+ for anterior chamber cells and have visual acuity of at least 20/400 in the study eye. Up to seven participants may be enrolled, as up to two participants may be accrued to replace enrolled participants who withdraw from the study prior to receiving any study medication.
Design: This is a Phase I, non-randomized, prospective, uncontrolled single-center study to evaluate subconjunctival sirolimus as a treatment for active anterior uveitis. All participants will receive a single 30-microL (1,320 microg) subconjunctival sirolimus injection in the study eye at baseline and will be followed for 16 weeks post-injection.
Outcome Measures: The primary outcome is the number of participants who experience at least a 2-step reduction in anterior chamber inflammation within four weeks post-injection. Secondary outcomes include changes in visual acuity and anterior chamber inflammation grading, the number of participants who experience a disease flare within the 16-week study duration and, of the participants who experience a disease flare, the number of days to disease flare from baseline. Secondary outcomes also include the presence or extent of cystoid macular edema.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 09-EI-0116 | None | None | View |