Topical Interferon Gamma for Macular Edema Secondary to Uveitis
NCT ID: NCT01376362
Last Updated: 2012-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2011-06-30
2012-03-31
Brief Summary
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Detailed Description
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Study Population: Five participants with CME as evidenced by OCT (\> 275 microns central macular thickness and/or loss of foveal contour) secondary to uveitis will receive topical ocular instillations of interferon gamma-1b. Up to seven participants may be enrolled in order to obtain the five participants to be included in the analysis if participants withdraw prior to receiving interferon gamma-1b.
Design: This Phase I/II, non-randomized, prospective, uncontrolled, single-center study will involve instilling four drops of interferon gamma-1b (approximately 30 μg) topically on the cornea of the study eye four times a day for one week and measuring the potential response with optical coherence tomography (OCT).
Outcome Measures: The primary outcome is the change in excess central macular thickening as measured by OCT in response to interferon gamma-1b. Treatment success is defined as a 25% decrease in excess central macular thickening at Week 1 as compared with baseline. Secondary efficacy outcomes include changes in macular volume as measured by OCT, visual acuity, intraocular pressure and intraocular inflammation as graded upon slit lamp examination. Secondary safety outcomes include ocular surface irritation assessed by fluorescein staining of the cornea and conjunctiva to assess toxicity, the number and severity of systemic and ocular toxicities, the number of adverse events and the proportion of participants with a visual loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Interferon gamma-1b
Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
Interferon Gamma-1b
Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
Interventions
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Interferon Gamma-1b
Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant must understand and sign the protocol's informed consent document.
3. Participant has a diagnosis of CME (central thickness of \>275 microns on OCT and/or disruption of foveal contour) secondary to uveitis in at least one eye (the study eye).
4. Participant is willing to comply with the study procedures and is expected to be able to return for all study visits.
5. Participant has visual acuity of 20/400 or better in the study eye.
6. Female participants of childbearing potential must not be pregnant or breast-feeding.
7. Both female participants of childbearing potential and male participants able to father a child must agree to practice two acceptable forms of contraception during the study and for six weeks following the last 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 with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy).
Exclusion Criteria
2. Participant has a significant active infection (an infection requiring treatment as determined by the medical team) that in the principal investigator's best medical judgment would preclude participation.
3. Participant has multiple sclerosis (MS), as interferon gamma may cause MS exacerbations.
18 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Responsible Party
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Nida Sen
Principal Investigator, NEI
Principal Investigators
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Hatice Nida Sen, MD, MHSc
Role: PRINCIPAL_INVESTIGATOR
National Eye Institute (NEI)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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Battle TE, Lynch RA, Frank DA. Signal transducer and activator of transcription 1 activation in endothelial cells is a negative regulator of angiogenesis. Cancer Res. 2006 Apr 1;66(7):3649-57. doi: 10.1158/0008-5472.CAN-05-3612.
Khorana HG. Rhodopsin, photoreceptor of the rod cell. An emerging pattern for structure and function. J Biol Chem. 1992 Jan 5;267(1):1-4. No abstract available.
Shi G, Maminishkis A, Banzon T, Jalickee S, Li R, Hammer J, Miller SS. Control of chemokine gradients by the retinal pigment epithelium. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4620-30. doi: 10.1167/iovs.08-1816. Epub 2008 Apr 30.
Other Identifiers
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11-EI-0167
Identifier Type: OTHER
Identifier Source: secondary_id
110167
Identifier Type: -
Identifier Source: org_study_id