Abstract
Purpose: :
To investigate the clinical efficacy and safety of an additional core vitrectomy to the standard therapy in patients with exsudative age-related macular degeneration (ARMD).
Methods: :
In this prospective, controlled, single-centre study 50 eyes of 50 patients (mean age: 74,1±7,1; median 74 (69/78)) with ARMD were enrolled and randomized 1:1 to group 1 - core vitrectomy additional to three times injections of ranibizumab (3xRbz) or group 2 - 3xRbz (control). In group 1 16/25 eyes (64%) and 12/25 (48%) in group 2 had a posterior vitreous detachment (PVD) prior to study start. Changes in best corrected visual acuity (ETDRS), central macular thickness and macular volume (OCT) as well as the rate of reinjection with an OCT based PRN protocol were monitored prospectively over 48 weeks.
Results: :
47 eyes for completed follow-up at week 48. In group 1, 4/24 were stable within 1 line (16,67%), 3/24 lost more than 1 line (12,5%) and 17/24 gained more than 1 line (70,83%) and improved in average by 9,75 letters. In group 2, 3/23 remained stable within 1 line, 18/23 gained more than 1 line (78,26%) resulting in 14,3 letters.Central macular thickness decreased by 85,5834µm (28,8%) in group 1 and by 121,4347µm (32,68%) in group 2 compared to baseline.In group 1, four patients received three additional and two patients two additional Rbz injections. In group 2, three patients received three additional, three patients two and 12 patients one additional Rbz injections. This yielded in an average injection rate of 3,66 in group 1 and 4,13 in group 2 over 48 weeks.PVD was identified in group 1 in 20/24 (83%) and in group 2 in 13/23 (56%) patients, which was not correlated with any outcome measure. No systemic or ocular adverse events were noticed.
Conclusions: :
An initial core vitrectomy combined with a conventional ranibizumab injection regimen for exudative ARMD patients was safe and lead to similar functional results with less intravitreal ranibizumab injections over 48 weeks.
Keywords: age-related macular degeneration