At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Phase I/II Study of the Treatment of Classic Central Serous Chorioretinopathy With Topical Interferon Gamma-1b
In Brief
A Phase 2 clinical trial evaluating Interferon gamma-1b for Retinal Disease and Macular Disease. Completed, enrolled 5 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Participant 1: 2 drops of topical interferon gamma-1b three times daily in the study eye for a daily dose of 42 μg Participant 2: 3 drops 3 times daily in the study eye for a daily dose of 63 μg, if the 1st participant's dose is deemed well-tolerated by the investigator at Weeks 1, 2 and 4. Participant 3: 3 drops 4 times daily in the study eye for a daily dose of 84 μg, if the 2nd tolerates the daily dose of 63 μg at Weeks 1, 2 and 4. Participants 4 and 5: 4 drops 4 times daily in the study eye for a daily dose of 112 μg, if the 3rd tolerates the daily dose of 84 μg at Weeks 1, 2 and 4. If the 63, 84 or 112 μg doses are not well-tolerated, subsequent participants will be enrolled at the prior dose level (42, 63 or 84 μg). Well-tolerated is defined as no corneal irritation (e.g., punctuate epithelial keratitis), no coexisting conjunctival erythema and edema, and no signs of more serious toxicities (e.g., intraocular inflammation or lens changes).