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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Icahn School of Medicine at Mount Sinai.
Recruitment status was  Recruiting
Information provided by:
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
First received: August 14, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.

Condition Intervention Phase
Diabetic Macular Edema
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 Diabetic Macular Edema

Resource links provided by NLM:

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

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
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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 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.

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959725

Contact: Roje-Oktay Kacmaz, MD 212-824-7645 roje-oktay.kacmaz@mssm.edu
Contact: Farzin Forooghian, MD 212-241-0939 ext 40939 farzin.forooghian@mssm.edu

United States, New York
Department of Ophthalmology, Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Farzin Forooghian, MD    212-241-0939 ext 40939    farzin.forooghian@mssm.edu   
Contact: Roje-Oktay Kacmaz, MD    212-824-7645    roje-oktay.kacmaz@mssm.edu   
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         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Farzin Forooghian, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Farzin Forooghian, MD, Assistant Professor, Department of Ophthalmology, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00959725     History of Changes
Other Study ID Numbers: GCO # 09-1195 
Study First Received: August 14, 2009
Last Updated: August 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Icahn School of Medicine at Mount Sinai:
Macular Edema

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 24, 2016