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

August 14, 2009 updated by: Icahn School of Medicine at Mount Sinai
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Participants with diabetic 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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Department of Ophthalmology, Mount Sinai School of Medicine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Scott E Brodie, MD
        • Sub-Investigator:
          • Robin N Ginsburg, MD
        • Sub-Investigator:
          • Pawan Bhatnagar, MD
        • Sub-Investigator:
          • Patricia Phak, MD
        • Sub-Investigator:
          • Roje-Oktay Kacmaz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participant must be 18 years of age or older.
  2. Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation.
  3. Participant must have a negative PPD skin test.
  4. Participant must understand and sign the protocol's informed consent document.

  5. Participants must have DME as defined by all of the following criteria:

    1. Presence of diabetes (type I or type II)
    2. Macular edema defined as a central macular thickness of ≥ 250μm on OCT.
  6. Participant must have visual acuity between 20/40 and hand motions in the study eye.
  7. Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
  8. 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.

If both eyes of a participant qualify for inclusion, then the eye with worse visual acuity will be chosen.

Exclusion Criteria:

  1. Participant is in another investigational study and actively receiving study therapy.
  2. Participant has proliferative diabetic retinopathy.
  3. Participant is unable to comply with study procedures or follow-up visits.
  4. Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
  5. Participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (e.g., uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
  6. Participant is expected to need ocular surgery or panretinal photocoagulation 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravitreal infliximab.
Drug: Infliximab (intravitreal, 2.0mg/0.05ml)
One injection of intravitreal infliximab (2.0mg/0.05ml).
Other Names:
  • Remicade™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Macular thickness
Time Frame: One, two, and three months
One, two, and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Farzin Forooghian, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2009

Last Update Submitted That Met QC Criteria

August 14, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO # 09-1195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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