Status:
WITHDRAWN
Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Genentech, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
Cell adhesion molecules are key mediators of inflammatory processes, which have been shown to play a role in the pathogenesis of diabetic retinopathy . Efalizumab inhibits the binding of leukocyte fun...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00676559
Start Date
April 1 2008
End Date
April 1 2010
Last Update
August 26 2016
Active Locations (10)
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1
Diego H. Calonje, M.D., P.C.
Tucson, Arizona, United States, 85712
2
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92101
3
Retina Macula Institute
Torrance, California, United States, 90503
4
Retina Associates of Maine
Bangor, Maine, United States, 04401