Retinal Disease Clinical Trial
Official title:
Pilot Phase I/II Study of the Treatment of Classic Central Serous Chorioretinopathy With Topical Interferon Gamma-1b
Verified date | November 2014 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 5 |
Est. completion date | February 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) | The Emmes Company, LLC |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Number of Severe Ocular Adverse Events Related to the Investigational Product | Week 48 | ||
Primary | Total Number of Ocular Adverse Events Related to Investigational Product | Week 48 | ||
Primary | Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product | Week 48 | ||
Primary | Total Number of Non-ocular Adverse Events Related to the Investigational Product | Week 48 | ||
Primary | Number of Participants Who Withdrew From the Study | Week 48 | ||
Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
Baseline and Week 2 | |
Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
Baseline and Week 2 | |
Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
Baseline and Week 48 | |
Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
Baseline and Week 48 | |
Secondary | Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline | Baseline and Week 2 | ||
Secondary | Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline | Baseline and Week 2 | ||
Secondary | Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 2 Compared to Baseline | Baseline and Week 2 | ||
Secondary | Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 2 Compared to Baseline | Baseline and Week 2 | ||
Secondary | Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 2 Compared to Baseline | Baseline and Week 2 | ||
Secondary | Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline | Baseline and Week 48 | ||
Secondary | Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline | Baseline and Week 48 | ||
Secondary | Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 48 Compared to Baseline | Baseline and Week 48 | ||
Secondary | Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 48 Compared to Baseline | Baseline and Week 48 | ||
Secondary | Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 48 Compared to Baseline | Baseline and Week 48 |
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