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

NCT00676559 | Withdrawn Phase 1 DMC

• 1 other identifier: NA 00015499
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

Conditions

Diabetic Macular Edema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of efalizumab, compared to and in combination with ranibizumab, measuring the frequency and severity of adverse events.

  6 mos

Secondary Outcomes (2)

• To measure the mean change from Baseline to Month 6 and Month 12 in Best correct visual acuity (BCVA)

  6 and 12 mos.

• To evaluate the anatomic retinal changes as assessed by color fundus photography, fluorescein angiography, and Optical Coherence Tomography (OCT)

  6 mos and 12 mos

Study Arms (3)

Group 1

EXPERIMENTAL

Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.

Drug: Efalizumab

Group 2

EXPERIMENTAL

Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).

Drug: Ranibizumab

Group 3

EXPERIMENTAL

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; Drug: Ranibizumab

Interventions

Efalizumab DRUG

Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.

Also known as: Raptiva

Group 1; Group 3

Ranibizumab DRUG

Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).

Also known as: Lucentis

Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent and authorization of use and disclosure of protected health information
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Juvenile Diabetes Research Foundation: collaborator
• Genentech, Inc.: collaborator

Study Sites (10)

Diego H. Calonje, M.D., P.C.

Tucson, Arizona, 85712, United States

Location

Sharp Rees-Stealy Medical Group

San Diego, California, 92101, United States

Location

Retina Macula Institute

Torrance, California, 90503, United States

Location

Retina Associates of Maine

Bangor, Maine, 04401, United States

Location

Retina Center of Maine

South Portland, Maine, 04106, United States

Location

Wilmer Eye Institute at the Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Edema

Interventions

efalizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Quan Dong Nguyen, MD, MSc

  Johns Hopkins University

  STUDY DIRECTOR

• Diana V Do, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

US (10)