Recruiting
Phase 1

Infliximab

Sponsor:

Retina Research Foundation

Code:

NCT00695682

Conditions

Diabetic Retinopathy

Macular Degeneration

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

intravitreal injection of infliximab

Study Details

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

Study ID

NCT00695682

Start date

Jun, 2008

Status verified date

Jun, 2008

Completion date

Dec, 2008

Anticipated

Primary completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Locations

Retina Consultants

Recruiting

SLingerlands, New York, United States, 12159

Contacts

Paul Beer, MD

518-533-6550

Principal Investigator:

Paul M Beer, MD

More Information

Sponsor

Retina Research Foundation

Last update posted

Jun 12, 2008

Last verified

Jun, 2008

Keywords

  • Remicade
  • Infliximab
  • CSME
  • BDR
  • CNV
  • AMD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Retina Research Foundation on 2008-06-12.