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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00959725
• Date of registration: 14/08/2009
• Primary sponsor: Mount Sinai School of Medicine
• Public title: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
• Scientific title: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
• Date of first enrolment: August 2009
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00959725
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Farzin Forooghian, MD

• Name: Roje-Oktay Kacmaz, MD

• Name: Farzin Forooghian, MD
• Affiliation: Mount Sinai School of Medicine

Key inclusion & exclusion criteria

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.

Exclusion Criteria:

1. Participant is in another investigational study and actively receiving study therapy.

2. Participant has proliferative diabetic retinopathy.

3. Participant is unable to comply with study procedures or follow-up visits.

4. Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.

5. 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.).

6. Participant is expected to need ocular surgery or panretinal photocoagulation in the
study eye during the course of the study.

7. Participant has undergone ocular surgery or an intravitreal/periocular steroid
injection in the study eye within the past 3 months.

8. Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in
the study eye within the past 6 weeks.

9. Participant has had a pars plana vitrectomy in the study eye.

10. Participant is on ocular or systemic medications known to be toxic to the lens,
retina, or optic nerve.

11. Participant with a history of ocular herpes simplex virus infection in the study eye.

12. A condition that, in the opinion of the investigator, would preclude participation in
the study (e.g., unstable medical status including blood pressure and glycemic
control).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Macular Edema

Intervention(s)

Drug: Infliximab (intravitreal, 2.0mg/0.05ml)

Primary Outcome(s)

Best-corrected visual acuity [Time Frame: Three months]

Secondary Outcome(s)

Macular thickness [Time Frame: One, two, and three months]

Secondary ID(s)

GCO # 09-1195

Source(s) of Monetary Support

Please refer to primary and secondary sponsors