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Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

2014-08-27 03:43:03 | BioPortfolio

Summary

This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration.

A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.

Description

This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness <225 microns).

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Choroidal Neovascularization

Intervention

Ranibizumab, Ranibizumab

Location

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

Status

Completed

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:03-0400

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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 pathological process consisting of the formation of new blood vessels in the CHOROID.

Excessive axial myopia associated with complications (especially posterior staphyloma and CHOROIDAL NEOVASCULARIZATION) that can lead to BLINDNESS.

A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.

A TIE receptor tyrosine kinase that is found almost exclusively on ENDOTHELIAL CELLS. It is required for both normal embryonic vascular development (NEOVASCULARIZATION, PHYSIOLOGIC) and tumor angiogenesis (NEOVASCULARIZATION, PATHOLOGIC).

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