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)

Abstract

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.

Sub-Macular Surgery: Is Still an Option for Age-Related Macular Degeneration?

“…The MARAN trial was unable to show the efficacy of MT360 surgery. The results of the MARAN trial failed to recruit a sufficient number of patients and the results of the 28 patients didn't show any differences between the two groups in terms of final visual, but rather showed that the reading function was superior after surgery [57].…”

“…The advent of pharmacological treatments, sometimes combined with gas and tissue plasminogen activator [58], have effectively opened new sceneries in the treatment of different forms of AMD [57]. The safety and the potential efficacy of submacular surgery has therefore been questioned.…”

“…The MARAN trial (Macular Relocation in Age-related Neovascular disease) was designed as a multicenter, prospective, randomised (1:1) clinical trial, whose aim was to assess the safety and the efficacy of macular translocation, taking into consideration difficulties and complications, such as proliferative vitreoretinopathy, double vision, etc. Patients were randomized to either surgery or a control group where they would receive standard treatment (observation or PDT) [57]. The recruitment rate, that was planned to be of 310 patients, was slow and the trial was stopped after finding only 28 patients.…”

“…Even more controversial is the submacular surgery for dry AMD. In 2001, a clinical randomized trial (MARAN trial) was set up to determine the efficacy of macular traslocation in patients with clinical signs and symptoms of exudative AMD, excluding those patients with classic and predominantly classic CNV [57]. The MARAN trial (Macular Relocation in Age-related Neovascular disease) was designed as a multicenter, prospective, randomised (1:1) clinical trial, whose aim was to assess the safety and the efficacy of macular translocation, taking into consideration difficulties and complications, such as proliferative vitreoretinopathy, double vision, etc.…”