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

• Status: Withdrawn
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Genentech, Inc.; Juvenile Diabetes Research Foundation
• Treatments: Antibodies, Monoclonal; Ranibizumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

• Inability to comply

• Patients receiving immunosuppressive agents

• All acellular, live and live-attenuated vaccines are excluded from 14 days prior to the first dose of efalizumab until a minimum of 4 weeks after the last dose of efalizumab

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.

• Participation in another simultaneous medical investigation or trial