Status:
COMPLETED
Topical Interferon Gamma-1b for Central Serous Chorioretinopathy
Lead Sponsor:
National Eye Institute (NEI)
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Retinal Disease
Macular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 m...
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. Th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01468337
Start Date
October 1 2011
End Date
February 1 2014
Last Update
January 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892