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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Edema	Drug: Efalizumab; Drug: Ranibizumab	Phase 1

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 function-associated antigen-1 (LFA-1) to intercellular adhesion molecule-1 (ICAM-1) thereby inhibiting the adhesion of leukocytes to other cell types.

Clinical studies have demonstrated the bioactivities of intravitreal ranibizumab, a Vascular endothelial growth factor (VEGF) antagonist, in reducing retinal thickness and improving visual acuity in patients with diabetic macular edema (DME).

The objective of the CAPTURE Study is to assess the safety and tolerability of efalizumab, administered subcutaneously as a weekly (1 mg/kg) dose, compared to and in combination with ranibizumab, administered intravitreally (0.5 mg), in the treatment of DME.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study
Study Start Date :	April 2008
Estimated Primary Completion Date :	April 2009
Estimated Study Completion Date :	April 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Group 1; Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.	Drug: Efalizumab; Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.; Other Name: Raptiva
Experimental: Group 2; Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).	Drug: Ranibizumab; Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).; Other Name: Lucentis
Experimental: Group 3; Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks in combination with ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).	Drug: Efalizumab; Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.; Other Name: Raptiva Drug: Ranibizumab; Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).; Other Name: Lucentis

Outcome Measures

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Primary Outcome Measures :

1. To assess the safety and tolerability of efalizumab, compared to and in combination with ranibizumab, measuring the frequency and severity of adverse events. [ Time Frame: 6 mos ]

Secondary Outcome Measures :

1. To measure the mean change from Baseline to Month 6 and Month 12 in Best correct visual acuity (BCVA) [ Time Frame: 6 and 12 mos. ]
2. To evaluate the anatomic retinal changes as assessed by color fundus photography, fluorescein angiography, and Optical Coherence Tomography (OCT) [ Time Frame: 6 mos and 12 mos ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Diego H. Calonje, M.D., P.C.
Tucson, Arizona, United States, 85712
United States, California
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92101
Retina Macula Institute
Torrance, California, United States, 90503
United States, Maine
Retina Associates of Maine
Bangor, Maine, United States, 04401
Retina Center of Maine
South Portland, Maine, United States, 04106
United States, Maryland
Wilmer Eye Institute at the Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
United States, Texas
Texas Retina Associates
Arlington, Texas, United States, 76012
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Johns Hopkins University

Juvenile Diabetes Research Foundation

Genentech, Inc.

Investigators

Study Director:	Quan Dong Nguyen, MD, MSc	Johns Hopkins University
Principal Investigator:	Diana V Do, MD	Johns Hopkins University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Quan Dong Nguyen, MD, MSc, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00676559 History of Changes
Other Study ID Numbers:	NA 00015499
First Posted:	May 13, 2008
Last Update Posted:	August 26, 2016
Last Verified:	August 2016

Keywords provided by Johns Hopkins University:

Diabetic; Macular; Edema; DME; Clinically Significant Macular Edema (CSME)

Additional relevant MeSH terms:

Edema; Macular Edema; Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Ranibizumab	Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antineoplastic Agents