Surgical management of subfoveal choroidal neovascular membranes in age-related macular degeneration by macular relocation: experiences of an early-stopped randomised clinical trial (MARAN Study).

摘要

RATIONALE: The MARAN (Macular Relocation in Age-related Neovascular disease) trial was planned to assess the effectiveness of full macular relocation (MR) in patients with neovascular age-related macular degeneration (AMD). DESIGN: Randomised, prospective, controlled clinical trial. METHODS: Patients suffering from visual loss because of AMD were randomised to either surgery or a control group receiving standard treatment (observation or photodynamic therapy (PDT)). The primary end point was the change of visual acuity (VA) (ETDRS) 52 weeks after randomisation compared with initial VA, and secondary end points included reading performance, contrast sensitivity, stability of fixation, eye-specific quality of life, and the absolute number of letters read correctly at 52 weeks compared with initial examination. RESULTS: Owing to early determination, only 28 patients were included in the study. The study did not show a difference between the two groups with respect to the final visual result or any of the secondary outcomes measured. The study was limited by the low recruitment that was, at least in part, attributed to the inherent risks for those patients randomised to the surgical arm of the study as well as to the emerging new treatments for AMD. CONCLUSION: The results of the MARAN trial failed to recruit a sufficient number of patients and a superiority of surgery over observation or PDT in patients with exudative AMD was not shown. There was a trend that the reading function was superior after surgery. In the light of the new pharmacological treatments, surgical options such as MR will be an option for only selected cases.