Status:
COMPLETED
The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Background: * Uveitis is a serious inflammatory condition that affects the eye and can cause vision loss. A common secondary problem associated with uveitis is macular edema (swelling). The macula is...
Detailed Description
Objective: Information gathered from our laboratories suggests that cystoid macular edema (CME) is caused by the disequilibrium of the Jak/Stat and mTor signal transduction pathways in the retinal pig...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant must be 18 years of age or older.
- Participant must understand and sign the protocol's informed consent document.
- Participant has a diagnosis of intermediate, panuveitis or posterior uveitis at least three months prior to study enrollment and has associated CME secondary to uveitis in at least one eye (the study eye).
- Participant has a central macular thickness greater than or equal to 250 microns in the study eye.
- Participant is willing to comply with the study procedures and is expected to be able to return for all study visits.
- Participant has visual acuity of 20/200 or better in the study eye.
- Female participants of childbearing potential must not be pregnant or breast-feeding.
- Both female participants of childbearing potential and male participants able to father a child must agree to practice an adequate contraception during the study and for six weeks following the administration of study medication. Acceptable methods of contraception include hormonal contraception (i.e. birth control pills, injected hormones dermal patch or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy).
- EXCLUSION CRITERIA:
- Participant is expected to be unable to tolerate the ocular instillation.
- Participant is unable to undergo OCT testing.
- Participant had herpes keratitis in the past.
- Participant is diagnosed with multiple sclerosis.
- Participant has a significant active infection (an infection requiring treatment as determined by the medical team) or a history of chronic or recurrent infections that in the principal investigator's best medical judgment would preclude participation.
Exclusion
Key Trial Info
Start Date :
July 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00943982
Start Date
July 17 2009
End Date
June 24 2010
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