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An Open-label Extension Study to Evaluate the Safety of Ranibizumab as Symptomatic Treatment for Visual Impairment Due to Diabetic Macular Edema in Patients

2014-07-23 21:14:24 | BioPortfolio

Summary

This study will characterise the safety profile of ranibizumab in patients with diabetic macular edema over an additional 24 months, following the initial 12-month treatment in the RESTORE study.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetic Macular Edema

Intervention

ranibizumab

Location

Novartis Investigative SIte
Vancouver
British Columbia
Canada
V5Z 3N9

Status

Enrolling by invitation

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:14:24-0400

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Medical and Biotech [MESH] Definitions

Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90)

Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.

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 form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION.

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