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K. Koch, D. Wong, P. Walter, B. Kirchhof, J. Dreyhaupt, C. Bauer, J. Munzinger, M. Seibert-Grafe, N. Victor, A. M. Joussen; Surgical Management of Subfoveal Choroidal Neovascular Membranes in Age Related Macular Degeneration by Macular Translocation,Experiences of an Early Halted Randomized Clinical Trial (MARAN Study). Invest. Ophthalmol. Vis. Sci. 2008;49(13):584.
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The MARAN trial was planned to assess the effectiveness of full macular translocation in patients with neovascular age-related macular degeneration and early stopped because of low recruitment.
Patients suffering from visual loss due to neovascular age related macular degeneration (ARMD) were randomized to either surgery or a control group receiving standard treatment (observation or photodynamic therapy). The primary endpoint was the change of visual acuity (ETDRS) at 52 weeks after randomization compared to initial visual acuity, secondary endpoints included reading performance, contrast sensitivity, stability of fixation, eye specific quality of life, and the absolute number of letters read correctly at 52 weeks after randomization compared to initial examination.
A total of 28 patients were included into the study. The study shows no difference with respect to the visual outcome, nor any of the secondary outcomes measured. The study was complicated by the low recruitment what can be attributed to the difficulty in the decision between a major operation and conservative treatment, as well as the emerging new treatments for ARMD.
The results of this randomized clinical trial fail to demonstrate a superiority of surgery over observation or photodynamic therapy (PDT) in patients with exudative ARMD, perhabs of the early stop. Still there is a trend that reading function is superior after surgery. In the light of the new pharmacological treatments surgical options such as macular translocation will be an option for only selected cases, however, the conclusions from this trial are limited by the small number of patients included.
Clinical Trial: :
ethics commission # EK 01-181
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