Topical Interferon Gamma-1b for Central Serous Chorioretinopathy
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
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).