Topical Interferon Gamma-1b for Central Serous Chorioretinopathy

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Background:

• In the eye disease central serous chorioretinopathy (CSC), fluid collects under the retina at the back of the eye. CSC can resolve on its own, but in some people it lasts for several months or can come back. The fluid buildup during CSC can cause vision loss. The drug interferon gamma-1b can help reduce fluid accumulation in the retina. Researchers want to see if interferon gamma-1b can help treat and prevent vision loss from CSC.

Objectives:

• To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC.

Eligibility:

• Individuals at least 18 years of age who have CSC in at least one eye.

Design:

• Participants will be screened with a physical exam and medical history. They will also have an eye exam and blood tests.

• This study will require at least ten visits to the National Institutes of Health eye clinic over a total of 52 weeks (one year). Most visits will last up to 4 hours.

• Participants will return to the eye clinic 2 days after the first visit and 1, 2, 4, 8, 12, 24, 36 and 48 weeks after starting the study eye drops. These visits will involve blood tests and eye exams.

• Participants will receive the study eye drops at the initial visit. The drops must be used three or four times a day for 2 weeks. They must be stored in a cool place (like a refrigerator). The doses will follow an escalation schedule with the first participant receiving 2 drops three times a day and the last participant receiving 4 drops four times a day. To maximize safety, the most-recently enrolled participant will complete Week 4 before the next participant can enroll (e.g., the second enrolled participant will not be enrolled until the first has completed the Week 4 visit).

• If the CSC does not improve after the first 2 weeks, participants will receive another 2 weeks of eye drops. This set of drops will start 4 weeks after the initial study visit.

• If the CSC does not improve after the 8-week study period, participants may receive additional eye drops at the maximum dose of 4 drops four times daily.

• The study will end for each participant at one year (48 weeks after the initial study visit).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Eye Institute (NEI)
• Collaborators: The Emmes Company, LLC; The EMMES Corporation
• Treatments: Interferon-gamma; Interferons

Criteria

• INCLUSION CRITERIA:

• Participant must be 18 years of age or older.

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

• Female participant of childbearing potential (see Appendix 1 for definition) must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo pregnancy tests at scheduled study visits.

• Female participant must be post-menopausal (see Appendix 1), must have had a hysterectomy, have a partner with a vasectomy, be completely abstinent from intercourse or must agree to practice two reliable methods of contraception throughout the course of the study and for six weeks after 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 (diaphragm, condom) with spermicide; or

• surgical sterilization (tubal ligation).

EXCLUSION CRITERIA:

• Participant is actively receiving an investigational medication in another research trial that may have unknown effects on CSC as determined by the investigator.

• Participant has evidence of ocular disease other than CSC in the study eye that may confound the outcome of the study (e.g., neovascular age-related macular degeneration).

• Participant has evidence of choroidal neovascularization (CNV) in the study eye.

• Participant is expected to need ocular surgery in the study eye during the eight weeks of the study.

• Participant is expected to need focal laser treatment or photodynamic therapy (PDT) in the study eye during the eight weeks of the study.

• Participant is on medications that enhance RPE pumping of fluid (e.g., acetazolamide).

• Participant is on steroid medication (oral (e.g., prednisone), topical (e.g., hydrocortisone cream) or inhaled (e.g., fluticasone inhaler)).

• Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study (e.g., Hypertension not controlled with medications or active infection requiring treatment).

• Participant is allergic to fluorescein dye.

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

• Participant is on anti-cortisol or anti-androgen medications (e.g., finasteride or mifepristone), as there is some data suggesting that these medications may reduce CSC fluid.