Abstract
Purpose: :
Interim European multi-center clinical study results of suprachoroidal drug delivery with the use of a microcatheter for the treatment of advanced, exudative age-related macular degeneration (AMD).
Methods: :
prospective study, 3 study centers (Pisa, Karlsruhe, Berlin).Inclusion criteria: AMD patients who have failed multiple conventional treatments (Lucentis®, Avastin®, PDT), with lesion size ≥ 4 Disk Area and Visual Acuity (VA) 20/400 to 20/40.Patients (pts) underwent single combination treatment: 1.25 mg Avastin + 4 mg Triamcinolone administered to macular region of suprachoroidal space through a microcatheter (iTRACKTM 400, iScience Interventional Corporation) introduced performing a 2-3 mm dissection at the pars plana and advanced posteriorly while visualizing the illuminated tip beneath the retina through the operating microscope. Patients follow-up was scheduled for 1 3,6 months post-surgery. Study parameters at 12 months were LogMAR VA, fluorescein angiography (FA), OCT and surgical complications
Results: :
21 pts were enrolled to date, no surgical complications have been observed. At baseline (21 pts) mean (m) LogMAR VA was 0.98 (SD 0.34), m. macular thickness on the OCT was 407 (SD 230). At 6 months (10 pts) m LogMAR VA was 0.97 (SD 0.28) ,m. macular thickness was 408 (SD 296). 29% of eyes improved more than 2 lines.Data at each follow-up were shown in table 1
Conclusions: :
Suprachoroidal drug administration directly adjacent to the choroid in the submacular region may be a potential treatment for advanced AMD. Administering therapeutic agents through the suprachoroidal space may be desirable to allow for direct drug exposure to the choroid, potentially increasing choroidal drug levels.
Keywords: age-related macular degeneration • vitreoretinal surgery • macula/fovea