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

Primary Purpose

Diabetic Retinopathy, Macular Degeneration

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

intravitreal injection of infliximab

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Remicade, Infliximab, CSME, BDR, CNV, AMD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Retina ConsultantsRecruiting

Outcomes

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)

Secondary Outcome Measures

(BCVA)

Standard Electroretinogram

OCT

Fluorescein angiography

Nidek Microperimetry

Incidence and severity of adverse events

Full Information

NCT ID

NCT00695682

First Posted

June 10, 2008

Last Updated

June 11, 2008

Sponsor

Retina Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00695682

Brief Title

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

Acronym

ITVR

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 Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2008 (Anticipated)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Retina Research Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy, Macular Degeneration

Keywords

Remicade, Infliximab, CSME, BDR, CNV, AMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

intravitreal injection of infliximab

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

(BCVA)

Time Frame

Title

Standard Electroretinogram

Time Frame

Title

OCT

Time Frame

Title

Fluorescein angiography

Time Frame

Title

Nidek Microperimetry

Time Frame

Title

Incidence and severity of adverse events

Time Frame

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul M Beer, MD

Organizational Affiliation

Retina Research Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Retina Consultants

City

SLingerlands

State/Province

New York

ZIP/Postal Code

12159

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Beer, MD

Phone

518-533-6550

First Name & Middle Initial & Last Name & Degree

Paul M Beer, MD

12. IPD Sharing Statement

Links:

URL

http://retinaresearchfoundation.org

Description

Retina Research Foundation

URL

http://retinaconsultants.org

Description

Retina Consultants

Learn more about this trial

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

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