Topical Interferon Gamma-1b for Central Serous Chorioretinopathy
- 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.
- To see interferon gamma-1b eye drops are a safe and effective treatment for CSC.
- Individuals at least 18 years of age who have CSC in at least one eye.
- 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 six visits to the National Institutes of Health eye clinic over 8 weeks. Each visit will last up to 4 hours.
- 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).
- Participants will return to the eye clinic 2 days after the first visit and 1, 2, 4, and 8 weeks after starting the study eye drops. These visits will involve blood tests and eye exams.
- If the CSC does not improve after the first 2 weeks, participants will receive another 2 weeks of eye drops. This set will start 4 weeks after the initial study visit.
- The study will end with the final visit, 8 weeks after the initial study visit.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Phase I/II Study of the Treatment of Classic Centeral Serous Chorioretinopathy With Topical Interferon Gamma-1b|
- The primary outcome measure related to the safety and tolerability of serial ocular instillations of topical interferon gamma-1b will be assessed by the number and severity of AEs related to the investigational product and the number of withdraw... [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Changes in BCVA, central retinal thickness and maximum lesion volume as measured on OCT, leakage as observed on FA, autofluorescence patterns as observed on FAF imaging and mean macular sensitivity as assessed by microperimetry. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Objective: Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina thought to be due to excessive choroidal hyperpermeability. The retinal pigment epithelium (RPE) plays a critical role in removing fluid from the subretinal space. This RPE pump is believed to be a key player in the reabsorption of subretinal fluid and maintenance of retinal attachment (9). Fluid transport assays have examined whether interferon gamma induces changes in fluid transport (JV) across human fetal RPE monolayers and showed an increase in fluid absorption from the retinal to the choroidal side of the tissue. An in vivo rodent model of retinal detachment (11) has been used to measure the effect of interferon gamma on re-absorption following retinal detachment and showed that the addition of interferon gamma to the anterior eye surface caused a significant, rapid decrease in retinal detachment volume in the first hour of observation (10). This pilot study will investigate the safety, tolerability and potential efficacy of serial ocular instillations of topical interferon gamma-1b for classic CSC.
Study Population: Five participants with subretinal fluid due to classic CSC will initially be enrolled. However, up to an additional two participants may be enrolled in order to obtain the five participants to be included in the analysis if any participants withdraw from the study.
Design: In this Phase I/II, non-randomized, prospective, uncontrolled, dose-escalation, single-center pilot study, a series of ocular instillations of topical interferon gamma-1b will be administered in the study eye over a two-week period. If the fluid re-accumulates or increases, participants will be eligible for re-challenging with topical interferon gamma-1b in the study eye at Week 4. Participants will be followed for eight weeks. Participants may be eligible for additional re-challenges after the initial eight week study period ends if their fluid reaccumulates or increases further.
Outcome Measures: The primary outcome measure related to the safety and tolerability of serial ocular instillations of topical interferon gamma-1b will be assessed by the number and severity of adverse events (AEs) related to the investigational product and the number of withdrawals. Secondary efficacy outcomes include changes in best-corrected visual acuity (BCVA), central retinal thickness and maximum lesion volume as measured on optical coherence tomography (OCT), leakage as observed on fluorescein angiograms (FA), autofluorescence patterns as observed on fundus autoflourescence (FAF) imaging and mean macular sensitivity as assessed by microperimetry.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Catherine Meyerle, M.D.||National Eye Institute (NEI)|