Overview

Topical Interferon Gamma for Macular Edema Secondary to Uveitis

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to investigate the safety and efficacy of ocular instillations of interferon gamma-1b as a potential treatment for cystoid macular edema (CME) secondary to uveitis.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Interferon-gamma
Interferons
Criteria
Inclusion Criteria

1. Participant must be 18 years of age or older.

2. Participant must understand and sign the protocol's informed consent document.

3. Participant has a diagnosis of CME (central thickness of >275 microns on OCT and/or
disruption of foveal contour) secondary to uveitis in at least one eye (the study
eye).

4. Participant is willing to comply with the study procedures and is expected to be able
to return for all study visits.

5. Participant has visual acuity of 20/400 or better in the study eye.

6. Female participants of childbearing potential must not be pregnant or breast-feeding.

7. Both female participants of childbearing potential and male participants able to
father a child must agree to practice two acceptable forms of contraception during the
study and for six weeks following the last administration of investigational product.
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

1. Participant is unable to tolerate the ocular instillations or follow study procedures.

2. Participant has a significant active infection (an infection requiring treatment as
determined by the medical team) that in the principal investigator's best medical
judgment would preclude participation.

3. Participant has multiple sclerosis (MS), as interferon gamma may cause MS
exacerbations.