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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Retina Research Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Retina Research Foundation
ClinicalTrials.gov Identifier:
NCT00695682
First received: June 10, 2008
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Macular Degeneration
Drug: intravitreal injection of infliximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Retina Research Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • (BCVA) [ Time Frame: 3m ] [ Designated as safety issue: Yes ]
  • Standard Electroretinogram [ Time Frame: 3m ] [ Designated as safety issue: Yes ]
  • OCT [ Time Frame: 3m ] [ Designated as safety issue: Yes ]
  • Fluorescein angiography [ Time Frame: 3m ] [ Designated as safety issue: Yes ]
  • Nidek Microperimetry [ Time Frame: 3m ] [ Designated as safety issue: Yes ]
  • Incidence and severity of adverse events [ Time Frame: 3m ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00695682

Locations
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
Investigators
Principal Investigator: Paul M Beer, MD Retina Research Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Paul Beer, MD, Retina Research Foundation
ClinicalTrials.gov Identifier: NCT00695682     History of Changes
Other Study ID Numbers: 101606
Study First Received: June 10, 2008
Last Updated: June 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Research Foundation:
Remicade
Infliximab
CSME
BDR
CNV
AMD

Additional relevant MeSH terms:
Choroidal Neovascularization
Diabetic Retinopathy
Macular Degeneration
Macular Edema
Neovascularization, Pathologic
Cardiovascular Diseases
Choroid Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases
Vascular Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014