Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema

Icahn School of Medicine at Mount Sinai1 site in 1 country10 target enrollmentAugust 2009

ConditionsDiabetic Macular Edema

InterventionsInfliximab (intravitreal, 2.0mg/0.05ml)

DrugsInfliximab (intravitreal, 2.0mg/0.05ml)

Overview

Phase: Phase 1
Intervention: Infliximab (intravitreal, 2.0mg/0.05ml)
Conditions: Diabetic Macular Edema
Sponsor: Icahn School of Medicine at Mount Sinai
Enrollment: 10
Locations: 1
Primary Endpoint: Best-corrected visual acuity
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.

Detailed Description

Participants with diabetic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

August 2011

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

•Participant must be 18 years of age or older.
•Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation.
•Participant must have a negative PPD skin test.
•Participant must understand and sign the protocol's informed consent document.
•Participants must have DME as defined by all of the following criteria:
•Presence of diabetes (type I or type II)
•Macular edema defined as a central macular thickness of ≥ 250μm on OCT.
•Participant must have visual acuity between 20/40 and hand motions in the study eye.
•Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
•Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.

Exclusion Criteria

•Participant is in another investigational study and actively receiving study therapy.
•Participant has proliferative diabetic retinopathy.
•Participant is unable to comply with study procedures or follow-up visits.
•Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
•Participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (e.g., uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
•Participant is expected to need ocular surgery or panretinal photocoagulation in the study eye during the course of the study.
•Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
•Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
•Participant has had a pars plana vitrectomy in the study eye.
•Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.