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Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions

2010-07-15 17:00:00 | BioPortfolio

Summary

The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to retinal vein occlusion.

Description

The secondary objectives are to assess the bioactivity of 0.5 or 2.0 mg of ranibizumab in patients with macular edemas due to retinal vein occlusion by measuring the mean change from baseline in several parameters of visual function and retinal thickness at weeks 24 and 48. In addition, aqueous levels of cytokines and ranibizumab will be measured to assess for biomarkers of disease activity and response and to perform a pharmacodynamic analysis by correlating aqueous levels of ranibizumab with the above outcome measures. At week 24, patients will be re-randomized to receive laser photocoagulation to areas of capillary nonperfusion outside the fovea to assess the safety and tolerability of combination treatment with laser and ranibizumab.

Study Design

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

Conditions

Retinal Vein Occlusion

Intervention

Ranibizumab .5mg, Ranibizumab .5mg with laser, Ranibizumab 2.0 mg, Ranibizumab 2.o dose with laser

Location

Wilmer Eye Institute at Johns Hopkins University
Baltimore
Maryland
United States
21287

Status

Recruiting

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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Medical and Biotech [MESH] Definitions

A recombinant humanized monoclonal antibody fragment that binds VEGF-A to prevent its binding to VEGFR-1 and VEGFR-2 receptors. This activity reduces vessel permeability and angiogenesis in the treatment of neovascular age-related MACULAR DEGENERATION.

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

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