Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study

Withdrawn before enrolling · Phase 1

Conditions studied: Diabetic Macular Edema

In brief

This study looks to continue the study of anti-vegf therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined Anti-vegf and anti-inflammatory.

Key facts

Study ID

NCT00676559

Run by

Johns Hopkins University

People needed

0

Starts

2008-04-01

Expected to finish

2010-04-01

Last updated by the study team

2016-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent and authorization of use and disclosure of protected health information
• 18 years of Age
• Diagnosis of diabetes mellitus (type 1 or type 2)
• Serum HbA1c 5.5% within 12 months of randomization
• Retinal thickening (diabetic macular edema) involving the center of the fovea
• Diagnosis must be confirmed by fluorescein angiography and OCT images over 250
• Best corrected visual acuity score in the study eye of 20/40 to 20/320
• If a female of childbearing potential, a negative pregnancy test and commitment to the use of at least two forms of effective contraception.
• If a non-sterile male, commitment to the use of two forms of effective contraception.
• Demonstrate understanding of and ability to perform weekly self sub-cutaneous injections.

You may not qualify if…

• Panretinal or macular photocoagulation within 3 months of study entry in the study eye
• Use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry
• Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
• Current or history of prior treatment of psoriasis with subcutaneous efalizumab within 6 months of study entry
• Proliferative diabetic retinopathy in the study eye, with the exceptions of
• inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation OR
• tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
• Vitreomacular traction or epiretinal membrane in the study eye
• Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-months.
• Cataract surgery in the study eye within 3 months of study entry; (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
• History of vitreoretinal surgery in the study eye within 3 months of study entry
• Uncontrolled glaucoma .
• Blood pressure exceeding 180/100 (sitting) during the screening period
• Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin > or = 13%(HbA1c) value
• Renal failure requiring dialysis or renal transplant
• Premenopausal women unwilling to commit to adequate contraception
• History of other diseases or finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications
• International Normalized Ratio (INR) > or = 3.0 (e.g. due to current treatment with warfarin).
• History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment.
• Have a history of hypersensitivity to efalizumab
• Have a history of ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. Have a history of opportunistic infections.
• Have the presence or history of malignancy, including lymphoproliferative disorders.
• Have a history of thrombocytopenia, clinically significant hemolytic anemia, or unexplained anemia
• Have a platelet count < 100,000 cells/microliter (uL)

Where it is running

• Diego H. Calonje, M.D., P.C. — Tucson, Arizona, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• Retina Macula Institute — Torrance, California, United States
• Retina Associates of Maine — Bangor, Maine, United States
• Retina Center of Maine — South Portland, Maine, United States
• Wilmer Eye Institute at the Johns Hopkins University — Baltimore, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Eye Care Specialists — Kingston, Pennsylvania, United States
• Texas Retina Associates — Arlington, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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