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

This study has been withdrawn prior to enrollment.
(PI left institution (there are no data results for this study))
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00958906
First received: August 11, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Uveitic Macular Edema
Intraocular Inflammation
Drug: Infliximab (intravitreal, 2.0mg/0.05ml)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Best-corrected visual acuity [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Macular thickness [ Time Frame: One, two, and three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: August 2009
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: Intravitreal infliximab Drug: Infliximab (intravitreal, 2.0mg/0.05ml)
One injection of intravitreal infliximab (2.0mg/0.05ml).
Other Name: Remicade™

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958906

Locations
United States, New York
Department of Ophthalmology, Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Farzin Forooghian, MD Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Farzin Forooghian, MD, Assistant Professor, Department of Ophthalmology, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00958906     History of Changes
Other Study ID Numbers: GCO # 09-0611
Study First Received: August 11, 2009
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Infliximab
Uveitis
Macular Edema
Intraocular Inflammation

Additional relevant MeSH terms:
Edema
Inflammation
Macular Edema
Chorioretinitis
Uveitis
Signs and Symptoms
Pathologic Processes
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Retinitis
Choroiditis
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Panuveitis
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014