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Topical Interferon Gamma for Macular Edema Caused by Uveitis

Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anterior Uveitis; Uveitis

Intervention: Interferon Gamma-1b (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: National Eye Institute (NEI)

Overall contact:
Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov

Summary

Background:

- Uveitis is a serious eye condition in which the immune system attacks the eye and can

cause vision loss. A common problem related to uveitis is macular edema. This is a swelling of the central part of the retina. This part of the retina is needed for sharp, clear vision. This swelling can lead to more vision loss.

- Interferon gamma-1b is a lab-created protein that acts like the material made by the

white blood cells that help fight infection. It changes the way the immune system reacts to the cells in the eye and may help to lessen the swelling in the back of the eye. It has been used as an injection to treat other immune diseases, but it has not been tested as an eye drop for use in uveitis other than a safety trial done at NIH in 2010.

Objectives:

- To test the effectiveness of interferon gamma eye drops to treat macular edema caused by

uveitis.

Eligibility:

- Individuals at least 18 years of age who have autoimmune uveitis in one or both eyes, have

had it for at least 3 months, and as a result have macular edema in at least one eye.

Design:

- This study requires three visits to the study clinic over about 2 weeks. Each visit

will last 1 to 2 hours.

- Participants will be screened with a physical exam, medical history, and a full eye

exam. One eye will be designated as the study eye.

- Participants will place eye drops in the study eye four times a day for 1 week.

- At the second study visit (after 1 week), participants will have an eye exam and a

physical exam, and will return the eye drops.

- Participants will have a final study visit 1 week after the second visit, with a final

eye exam.

Clinical Details

Official title: The Treatment of Macular Edema Secondary to Uveitis Using Topical Interferon Gamma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The change in excess central macular thickening as measured by OCT in response to interferon gamma-1b.

Secondary outcome: Changes in macular volume as measure by OCT, visual acuity, intraocular pressure and intraocular inflammation as graded upon slit lamp examination.

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 and over 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 micrograms) 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 percentage 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 greater than or equal to 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

- INCLUSION CRITERIA:

- Participant must be 18 years of age or older.

- Participant must understand and sign the protocol's informed consent document.

- 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).

- Participant is willing to comply with the study procedures and is expected to be able

to return for all study visits.

- Participant has visual acuity of 20/400 or better in the study eye.

- Female participants of childbearing potential must not be pregnant or breast-feeding.

- 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:

- Participant is unable to tolerate the ocular instillations or follow study

procedures.

- 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.

- Participant has multiple sclerosis (MS), as interferon gamma may cause MS

exacerbations.

Locations and Contacts

Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States; Recruiting
Additional Information

NIH Clinical Center Detailed Web Page

Related publications:

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.

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. Review. 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. Epub 2008 Apr 30.

Starting date: May 2011
Last updated: November 16, 2011

Page last updated: December 08, 2011

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