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

Diabetic Macular Edema Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

• NCT number: NCT00676559
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 2008
• Completion date: April 2010