Topical Interferon Gamma-1b for Central Serous Chorioretinopathy

NCT01468337 | Completed Phase 1 Results

• 2 other identifiers: 12001312-EI-0013
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Retinal Disease; Macular Disease

Keywords

Central Serous Chorioretinopathy; Interferon-Gamma (IFN-Gamma); Jakstat; Retinal Eye Disease; Macular Eye Disease; CSC

Outcome Measures

Primary Outcomes (5)

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

  Week 48

• Total Number of Ocular Adverse Events Related to Investigational Product

  Week 48

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

  Week 48

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

  Week 48

• Number of Participants Who Withdrew From the Study

  Week 48

Secondary Outcomes (14)

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

  Baseline and Week 2

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

  Baseline and Week 2

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

  Baseline and Week 48

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

  Baseline and Week 48

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

  Baseline and Week 2

Study Arms (1)

Interferon gamma-1b

EXPERIMENTAL

Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.

Drug: Interferon gamma-1b

Interventions

Interferon gamma-1b DRUG

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).

Also known as: Actimmune®

Interferon gamma-1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead
• The Emmes Company, LLC: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 19898183 BACKGROUND

• Iida T, Kishi S, Hagimura N, Shimizu K. Persistent and bilateral choroidal vascular abnormalities in central serous chorioretinopathy. Retina. 1999;19(6):508-12. doi: 10.1097/00006982-199911000-00005.

  PMID: 10606450 BACKGROUND

• Prunte C, Flammer J. Choroidal capillary and venous congestion in central serous chorioretinopathy. Am J Ophthalmol. 1996 Jan;121(1):26-34. doi: 10.1016/s0002-9394(14)70531-8.

  PMID: 8554078 BACKGROUND

MeSH Terms

Conditions

Retinal Diseases; Macular Degeneration; Central Serous Chorioretinopathy

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Eye Diseases; Retinal Degeneration

Limitations and Caveats

After study completion, a participant presented with a cataract on 4/12/13 (last study dose:10/3/12 and TOTAL study dosage received: 2758 µg). Although age (58) was consistent with the possibility of cataract, relatedness to drug cannot be ruled out.

Results Point of Contact

• Title: Emily Chew, MD
• Organization: National Eye Institute

emily.chew@nih.gov

301-496-6583

Study Officials

• Emily Y Chew, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2011
• First Posted: November 9, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: January 30, 2024
• Results First Posted: November 19, 2014

Record last verified: 2014-11

Locations

US (1)