Uveitis Clinical Trial
Official title:
The Treatment of Macular Edema Secondary to Uveitis Using Topical Interferon Gamma
The objective of this study is to investigate the safety and efficacy of ocular instillations of interferon gamma-1b as a potential treatment for cystoid macular edema (CME) secondary to uveitis.
Objective: Information gathered from NEI laboratories suggests that cystoid macular edema
(CME) is caused by the disequilibrium of the JakStat and mTor signal transduction pathways
in the retinal pigment epithelium (RPE). We wish to investigate whether stimulating the
JakStat pathway with topically applied interferon gamma-1b can be a therapeutic intervention
for the treatment of CME secondary to uveitis. The objective of this study is to investigate
the safety and efficacy of ocular instillations of interferon gamma-1b as a potential
treatment for CME secondary to uveitis.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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