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The Treatment of Uveitic Cystoid Macular Edema With Topical Interferon Gamma

NCT00943982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-07-02

No results posted yet for this study

Summary

Background:

* Uveitis is a serious inflammatory condition that affects the eye and can cause vision loss. A common secondary problem associated with uveitis is macular edema (swelling). The macula is the part of the eye that is important for central vision, and swelling of the macula can lead to further vision loss. This condition is usually treated by medicines that target the immune system, but these medicines sometimes do not work or may cause side effects.
* Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein that can alter the way inflammatory cells work in the immune system. Interferon gamma-1b is given as an intramuscular injection; however, this study will use the drug as an eye drop. This study represents the first time that interferon gamma-1b is given as an eye drop. Researchers hope that interferon gamma-1b will treat macular edema by decreasing the swelling in the back of the eye.

Objectives:

\- To investigate the safety and effectiveness of treating uveitis-associated macular edema with interferon gamma-1b.

Eligibility:

\- Individuals 18 years of age and older who have been diagnosed with macular edema associated with uveitis (in one or both eyes) for at least 3 months.

Design:

* Participants will have three planned clinic visits during this study over the course of 2 weeks.
* All participants will have a medical history and eye examination.
* When receiving the drops, participants will have optical coherence tomography (a detailed scan of the retina) 60 minutes and 30 minutes before the drops; upon receiving the drops; and 30, 60, and 120 minutes after receiving the drops.
* After receiving the drops, participants will have another eye examination, blood drawn for samples, and further scans.
* Participants will be asked to return to the NIH Clinical Center 1 week after receiving the drops for an evaluation....

Conditions

  • Uveitis

Interventions

DRUG

Interferon Gamma 1-b

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-17
Primary Completion
2010-06-24
Completion
2010-06-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00943982 on ClinicalTrials.gov