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
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01148511
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:08:43-0400
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Medical and Biotech [MESH] Definitions
Ranibizumab
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.
Geographic Atrophy
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.
Vitreoretinal Surgery
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.
Retinal Degeneration
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)
Wet Macular Degeneration
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.
