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

• ClinicalTrials.gov Identifier: NCT00676559
• Recruitment Status: Withdrawn
• First Posted: May 13, 2008
• Last Update Posted: August 26, 2016
• Sponsor: Johns Hopkins University
• Collaborators: Juvenile Diabetes Research Foundation; Genentech, Inc.
• Information provided by: Johns Hopkins University

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

• 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:

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