Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to uveitis.

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Detailed Description

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Participants with uveitic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.

Conditions

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Uveitic Macular Edema Intraocular Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal infliximab

Group Type EXPERIMENTAL

Infliximab (intravitreal, 2.0mg/0.05ml)

Intervention Type DRUG

One injection of intravitreal infliximab (2.0mg/0.05ml).

Interventions

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Infliximab (intravitreal, 2.0mg/0.05ml)

One injection of intravitreal infliximab (2.0mg/0.05ml).

Intervention Type DRUG

Other Intervention Names

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Remicade™

Eligibility Criteria

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Inclusion Criteria

1. Participant must be 18 years of age or older.
2. Participant must understand and sign the protocol's informed consent document.
3. Participants must have uveitic macular edema in one eye as defined by all of the following criteria:

1. Presence of active intermediate uveitis or posterior uveitis.
2. Macular edema defined as a central macular thickness of ≥ 250 μm on OCT.
3. Uveitis must be noninfectious as determined by standard investigations used in the diagnostic investigation of uveitis.
4. Participant must have visual acuity between 20/40 and hand motions in the study eye.
5. Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
6. Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.

Exclusion Criteria

1. Participant is in another investigational study and actively receiving study therapy.
2. Participant is unable to comply with study procedures or follow-up visits.
3. Participant has uveitic macular edema (as defined above) in both eyes.
4. Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
5. Participant has evidence of ocular disease other than uveitis in either eye that may confound the outcome of the study (e.g., diabetic retinopathy, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
6. Participant is expected to need ocular surgery in the study eye during the course of the study.
7. Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
8. Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
9. Participant has had a pars plana vitrectomy in the study eye.
10. Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
11. Participant with a history of ocular herpes simplex virus infection in the study eye.
12. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
13. There are no criteria for inclusion/exclusion for the fellow eye. Only one eye can have macular edema in order for the potential participant to be considered for enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No