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Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to AMD

2014-07-23 21:08:43 | BioPortfolio

Summary

The purpose of the study is to compare the two treatment regimens for the patients suffering from secondary choroidal neovascularisation to the Age Related Macular Degeneration. The first treatment regimen is the approved treatment of the AMD which is one injection each month for three months and than re-treatment of the patients who have visual loss more that 5 letters with monthly controls (treat and observe). The second treatment regimen is one injection each month for three months and than extending the control period if the macula is dry during the monthly controls (Treat and extend) If the "Treat and extend" regimen is found effective and safe, the yearly ranibizumab injection number can be decreased and the frequent patient visits, risk of adverse events due to the intravitreal injections and policlinic occupation can be reduced.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Age Related Macular Degeneration

Intervention

Ranibizumab, Ranibizumab

Location

Novartis Investigative Site
Adana
Turkey

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:43-0400

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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 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.

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 retrogressive pathological change in the retina, focal or generalized, caused by genetic defects, inflammation, trauma, vascular disease, or aging. Degeneration affecting predominantly the macula lutea of the retina is MACULAR DEGENERATION. (Newell, Ophthalmology: Principles and Concepts, 7th ed, p304)

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.

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Ophthalmology is the branch of medicine that is devoted to the study and treatment of eye diseases. As well as mild visual defects correctable by lenses, ophthalmology is concerned with glaucoma, uveitis and other serious conditions affecting the eye, ...


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