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Topical Interferon Gamma-1b for Central Serous Chorioretinopathy

Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinal Disease; Macular Disease

Intervention: Interferon gamma-1b (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: National Eye Institute (NEI)

Official(s) and/or principal investigator(s):
Emily Y Chew, M.D., Principal Investigator, Affiliation: National Eye Institute (NEI)

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).

Clinical Details

Official title: Pilot Phase I/II Study of the Treatment of Classic Central Serous Chorioretinopathy With Topical Interferon Gamma-1b

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Total Number of Severe Ocular Adverse Events Related to the Investigational Product

Total Number of Ocular Adverse Events Related to Investigational Product

Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product

Total Number of Non-ocular Adverse Events Related to the Investigational Product

Number of Participants Who Withdrew From the Study

Secondary outcome:

Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline

Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline

Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline

Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline

Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline

Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline

Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 2 Compared to Baseline

Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 2 Compared to Baseline

Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 2 Compared to Baseline

Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline

Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline

Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 48 Compared to Baseline

Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 48 Compared to Baseline

Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 48 Compared to Baseline

Detailed description: 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. Fluid transport assays have examined whether interferon gamma induces changes in fluid transport 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 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. 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 one year. Participants may be eligible for additional re-challenges after the initial eight week study period ends if their fluid re-accumulates 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 autofluorescence (FAF) imaging and mean macular sensitivity as assessed by microperimetry.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States
Additional Information

Related publications:

Imamura Y, Fujiwara T, Margolis R, Spaide RF. Enhanced depth imaging optical coherence tomography of the choroid in central serous chorioretinopathy. Retina. 2009 Nov-Dec;29(10):1469-73. doi: 10.1097/IAE.0b013e3181be0a83.

Iida T, Kishi S, Hagimura N, Shimizu K. Persistent and bilateral choroidal vascular abnormalities in central serous chorioretinopathy. Retina. 1999;19(6):508-12.

PrĂ¼nte C, Flammer J. Choroidal capillary and venous congestion in central serous chorioretinopathy. Am J Ophthalmol. 1996 Jan;121(1):26-34.

Starting date: October 2011
Last updated: November 12, 2014

Page last updated: August 20, 2015

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