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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00876434 |
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 two participants may be replaced if they require the use of additional medications for the treatment of uveitis (other than topical steroids) in their active non-study eye prior to their Week 4 study visit.
Design: This is a Phase I, non-randomized, prospective and 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 inflammation within four weeks post-injection. Secondary outcomes include changes in visual acuity and anterior chamber cells, 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.
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Condition | Intervention | Phase |
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Anterior Uveitis |
Drug: Sirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveitis |
Estimated Enrollment: | 7 |
Study Start Date: | April 2009 |
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 two participants may be replaced if they require the use of additional medications for the treatment of uveitis (other than topical steroids) in their active non-study eye prior to their Week 4 study visit.
Design: This is a Phase I, non-randomized, prospective and 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 inflammation within four weeks post-injection. Secondary outcomes include changes in visual acuity and anterior chamber cells, 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Both female participants of childbearing potential and male participants able to father a child must agree to practice two* forms of adequate birth control throughout the course of the study and for three months post-injection. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy).
However, female participants with a tubal ligation (or male participants who have a female partner with a tubal ligation) are not exempt, and are required to practice another acceptable method of birth control.
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 090116, 09-EI-0116 |
Study First Received: | April 3, 2009 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00876434 History of Changes |
Health Authority: | United States: Federal Government |
Sirolimus Anterior Uveitis Autoimmune Disease |
Uveitis, Anterior Panuveitis Sirolimus Autoimmune Diseases Immunologic Factors Clotrimazole Eye Diseases |
Miconazole Tioconazole Immunosuppressive Agents Anti-Bacterial Agents Uveitis Antifungal Agents |
Uveitis, Anterior Panuveitis Sirolimus Anti-Infective Agents Uveal Diseases Immunologic Factors Antineoplastic Agents Eye Diseases |
Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Uveitis Therapeutic Uses Antifungal Agents |