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Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695682
Recruitment Status : Unknown
Verified June 2008 by Retina Research Foundation.
Recruitment status was:  Recruiting
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
Information provided by:
Retina Research Foundation

Brief Summary:

Injections of medicine into the middle of the eye (intravitreal injections) are commonly used in a multitude of retinal diseases. We are looking for new treatments that may be beneficial in treating retinal disease and improving patients' vision.

Infliximab (Remicade) is a genetically engineered antibody against a molecule in the body called TNF-α. It neutralizes the effects of TNF-α by binding to it. Intravenous Infliximab has been used for inflammatory arthritic conditions and Crohn's disease since 1998. We do not know if infliximab injections into the eye are safe. We are performing this pilot study to determine if they can be safe.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Degeneration Drug: intravitreal injection of infliximab Phase 1

Detailed Description:

Intravenous Infliximab is currently used for the treatment of systemic inflammatory conditions and inflammatory disease of the eye with a relatively favorable safety profile. However, systemic administration carries the risk of systemic side effects, which in the case of infliximab can be severe, such as increased risk of infection, reactivation of tuberculosis or Hepatosplenic T-cell Lymphoma.

Direct intravitreal administration of medication is the preferred method of treatment for retinal vascular disorders. The eye is a self contained organ relatively isolated from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug levels can be achieved with a much smaller amount of medication if injected intravitreally and this also results in minimal systemic exposure to the patient. Preliminary studies have shown that Infliximab may have a positive role in the management of retinal vascular disorders in humans when administered intravenously, and can be an effective treatment intravitreally in animal models. No data has been published yet on intravitreal use of infliximab in human subjects.

We plan to study the safety and tolerability of intravitreal injections of infliximab in human subjects with refractory diabetic macular edema or choroidal neovascularization. Our infliximab dose will be 0.5mg/0.5ml, as it follows the reconstitution instructions in the Product Insert. This dosing will fall within the therapeutic dosing found within the animal study as it leads to the same vitreous concentration as the7.5 µg dose in group B rat eye study. (4)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Tolerability of Intravitreal Infliximab (Remicade) in Patients With Refractory Diabetic Macular Edema or Choroidal Neovascularization Secondary to Age Related Macular Degeneration- A Pilot Study
Study Start Date : June 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Intervention Details:
  • Drug: intravitreal injection of infliximab
    All subjects will receive 0.5 mg/ 0.05 mL of infliximab by intravitreal injection at their first treatment visit or the 6 weeks visit if eligible for a repeat injection.

Primary Outcome Measures :
  1. This is a pilot study to study the safety and tolerability of intravitreal Infliximab in patients with refractory diabetic macular edema and choroidal neovascularization (CNV) [ Time Frame: 3 m ]

Secondary Outcome Measures :
  1. (BCVA) [ Time Frame: 3m ]
  2. Standard Electroretinogram [ Time Frame: 3m ]
  3. OCT [ Time Frame: 3m ]
  4. Fluorescein angiography [ Time Frame: 3m ]
  5. Nidek Microperimetry [ Time Frame: 3m ]
  6. Incidence and severity of adverse events [ Time Frame: 3m ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 21 years
  • Patients with active CNV secondary to AMD in the study eye which did not improve with conventional therapy
  • Patients with refractory diabetic macular edema in the study eye which did not improve with conventional therapy
  • BCVA 20/70 or less as measured on an ETDRS chart.

Exclusion Criteria:

  • Are participating in another clinical study requiring follow up examinations
  • Have received any other experimental drug within 12 weeks prior to enrollment
  • Are unwilling or unable to follow or comply with all study-related procedures
  • Inability to obtain photographs, fluorescein angiography, or optical coherence tomography to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access
  • Aphakia or pseudophakia with the absence of posterior capsule (unless it resulted from a yttrium aluminum garner [YAG]) posterior capsulotomy)
  • Within two months prior to screening, have had intraocular surgery (including cataract surgery) in the study eye
  • Within 1 month prior to screening had YAG laser in the study eye
  • Have had intravitreal anti VEGF or intravitreal steroids in the last 6 weeks
  • Have had previous pars plana vitrectomy in the study eye
  • Are pregnant or are trying to become pregnant
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Have a history of allergies to murine monoclonal antibodies, mice or mouse products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695682

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United States, New York
Retina Consultants Recruiting
SLingerlands, New York, United States, 12159
Contact: Paul Beer, MD    518-533-6550      
Principal Investigator: Paul M Beer, MD         
Sponsors and Collaborators
Retina Research Foundation
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Principal Investigator: Paul M Beer, MD Retina Research Foundation

Additional Information:
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Responsible Party: Paul Beer, MD, Retina Research Foundation Identifier: NCT00695682    
Other Study ID Numbers: 101606
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008
Keywords provided by Retina Research Foundation:
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Diabetic Retinopathy
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents