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The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal infliximab. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab (intravitreal, 2.0mg/0.05ml) | Drug | One injection of intravitreal infliximab (2.0mg/0.05ml). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected visual acuity | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Macular thickness | One, two, and three months |
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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:
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.
If both eyes of a participant qualify for inclusion, then the eye with worse visual acuity will be chosen.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roje-Oktay Kacmaz, MD | Contact | 212-824-7645 | roje-oktay.kacmaz@mssm.edu | |
| Farzin Forooghian, MD | Contact | 212-241-0939 | 40939 | farzin.forooghian@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Farzin Forooghian, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Mount Sinai School of Medicine | Recruiting | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19211094 | Background | Theodossiadis PG, Liarakos VS, Sfikakis PP, Vergados IA, Theodossiadis GP. Intravitreal administration of the anti-tumor necrosis factor agent infliximab for neovascular age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):825-30, 830.e1. doi: 10.1016/j.ajo.2008.12.004. Epub 2009 Feb 10. | |
| 18982345 | Background |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Theodossiadis PG, Liarakos VS, Sfikakis PP, Charonis A, Agrogiannis G, Kavantzas N, Vergados IA. Intravitreal administration of the anti-TNF monoclonal antibody infliximab in the rabbit. Graefes Arch Clin Exp Ophthalmol. 2009 Feb;247(2):273-81. doi: 10.1007/s00417-008-0967-4. Epub 2008 Nov 4. |
| 18326743 | Background | Giansanti F, Ramazzotti M, Vannozzi L, Rapizzi E, Fiore T, Iaccheri B, Degl' Innocenti D, Moncini D, Menchini U. A pilot study on ocular safety of intravitreal infliximab in a rabbit model. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1151-6. doi: 10.1167/iovs.07-0932. |
| 17846362 | Background | Olson JL, Courtney RJ, Mandava N. Intravitreal infliximab and choroidal neovascularization in an animal model. Arch Ophthalmol. 2007 Sep;125(9):1221-4. doi: 10.1001/archopht.125.9.1221. |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |