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

NCT00695682 | Unknown Phase 1

• 1 other identifier: 101606
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Macular Degeneration

Keywords

Remicade; Infliximab; CSME; BDR; CNV; AMD

Outcome Measures

Primary Outcomes (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)

  3 m

Secondary Outcomes (6)

• (BCVA)

  3m

• Standard Electroretinogram

  3m

• OCT

  3m

• Fluorescein angiography

  3m

• Nidek Microperimetry

  3m

Interventions

intravitreal injection of infliximab DRUG

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Retina Research Foundation: lead

Study Sites (1)

Retina Consultants

Slingerlands, New York, 12159, United States

RECRUITING

Related Links

• Retina Research Foundation
• Retina Consultants

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration

Study Officials

• Paul M Beer, MD

  Retina Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 12, 2008

Record last verified: 2008-06

Locations

US (1)