Status:
COMPLETED
Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Anterior Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 immuno...
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 eff...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant has the ability to understand and sign the informed consent document.
- Participant is 18 years of age or older.
- Participant's uveitis is considered active on current regimen.
- Participant has a diagnosis of non-infectious anterior uveitis requiring treatment to control their intraocular inflammatory disease with systemic and/or topical anti-inflammatory medications at high frequency intervals (greater than or equal to T.I.D.) or local steroid treatment (periocular steroid injections) is contraindicated because of significant IOP elevation with local steroid treatments in the past (steroid responder).
- Participant has anterior uveitis with at least a grade of 1+ for anterior chamber cells 1 in the study eye.
- Participant has visual acuity in the study eye of 20/400 or better (or ETDRS equivalent).
- Participant has normal renal or liver function, or no worse than mild abnormalities as defined by the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
- Participant has no history of intraocular surgery within three months prior to study enrollment and agrees not to undergo elective ocular surgery (e.g., cataract extraction) for the duration of the study.
- Participant has an absolute neutrophil count (ANC) above 750/mm(3)
- Participant is able to undergo full ophthalmic examination for assessment of anterior chamber cells.
- Participant understands there is an increased risk for skin cancer with sirolimus usage and agrees to practice skin protective measures for two weeks following their injection. Skin protective measures include: 1) staying out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible; 2) wearing protective clothing, including a hat and sunglasses; 3) applying a sun block product that has a skin protection factor (SPF) of at least 15 (some participants may require a product with a higher SPF number, especially if they have a fair complexion); 4) applying a sun block lipstick that has a SPF of at least 15 to protect the lips; and 5) not using a sun lamp or tanning booth or bed.
- Participant is willing and able to comply with the study procedures.
- Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative urine pregnancy test at screening and must be willing to undergo urine pregnancy tests throughout the study.
- 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).
- Participants with a hysterectomy or vasectomy (or have a partner with a hysterectomy or vasectomy) are exempt from using two methods of contraception. 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:
- Participant has a significant active infection (an infection requiring treatment as determined by the medical team) or a history of chronic or recurrent infections.
- Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years.
- Participant has used latanoprost (Xalatan (Registered Trademark)) within two weeks prior to study enrollment or is likely to need it at any point during the study as determined by the investigator.
- For participants with active anterior uveitis in both eyes, the participant's non-study eye is anticipated to require periocular steroids or it is anticipated that an increase in systemic immunosuppressive treatments including steroids may be required during the course of the study.
- Participant has a media opacity that precludes assessment of anterior chamber inflammation.
- Participant has active joint or systemic inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00876434
Start Date
April 1 2009
End Date
February 10 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892