Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01376362
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
2011-06-17
Brief Title:
Topical Interferon Gamma for Macular Edema Secondary to Uveitis
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Treatment of Macular Edema Secondary to Uveitis Using Topical Interferon Gamma
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JakStat2
Brief Summary:
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
Detailed Description:
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 andor 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 III 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
Study Population Five participants with CME as evidenced by OCT 275 microns central macular thickness andor 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 III 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11-EI-0167 | OTHER | CNS IRB | None |