Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00876434
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2009-04-03
Brief Title:
Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
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 patients 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 US 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 20400
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 patients 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 US 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 20400
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 andor 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 andor topical anti-inflammatory medications at high frequency intervals greater than or equal to three times daily TID or local steroid treatment periocular steroid injections is contraindicated because of significant intraocular pressure IOP elevation with local steroid treatments in the past ie steroid responder have at least a grade of 1 for anterior chamber cells and have visual acuity of at least 20400 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 1320 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 andor topical anti-inflammatory medications at high frequency intervals greater than or equal to three times daily TID or local steroid treatment periocular steroid injections is contraindicated because of significant intraocular pressure IOP elevation with local steroid treatments in the past ie steroid responder have at least a grade of 1 for anterior chamber cells and have visual acuity of at least 20400 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 1320 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 09-EI-0116 | None | None | None |