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

Inclusion Criteria

• •1. Participant must be 18 years of age or older.
• •2. Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation.
• •3. Participant must have a negative PPD skin test.
• •4. Participant must understand and sign the protocol's informed consent document.
• •5. Participants must have DME as defined by all of the following criteria:
• •1. Presence of diabetes (type I or type II)
• •2. Macular edema defined as a central macular thickness of ≥ 250μm on OCT.
• •6. Participant must have visual acuity between 20/40 and hand motions in the study eye.
• •7. Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
• •8. 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.
• •If both eyes of a participant qualify for inclusion, then the eye with worse visual acuity will be chosen.