PURPOSE: To investigate the clinical efficacy and safety of an additional core vitrectomy to the standard therapy in patients with exudative 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 (3x Rbz) and Group 2 - 3x Rbz (control). 1 16 of 25 eyes in Group 1(64%) and 12 of 25 (48%) in Group 2 had a posterior vitreous detachment (PVD) prior to start of the study. Changes in best-corrected visual acuity (BCVA) using ETDRS charts, central macular thickness and macular volume (OCT) as well as the rate of reinjection with an OCT-based pro renata (PRN) protocol were monitored prospectively over 48 weeks. Forty-seven eyes completed follow-up at week 48. RESULTS: In Group 1, 4 of 24 lost 1 line of BCVA (16.7%) and 3 of 24 lost 2 lines (12.5%), whereas 17 of 24 gained more than 1 line (70.8%) and improved in average by 9.8 letters. In Group 2, 3 of 23 remained stable and 20 of 23 gained more than or exactly 1 line (78.3%), resulting in 14.3 letters, with no loss of lines. Central macular thickness decreased by 85.58 μm (28.8%) in Group 1 and by 121.43 μm (32.68%) in Group 2 compared with 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 4.17 in Group 2 over 48 weeks. Posterior vitreous detachment (PVD) was identified in Group 1 in 16 of 24 (66.7%) and in Group 2 in 12 of 23 (52.2%) patients at baseline. At week 48, 6 of 8 (75%) of the patients in Group 1 with initial attached vitreous showed a vitreal detachment, whereas only 1 of 11 (9%) in Group 2 had a new occurred detachment of the vitreous. No systemic or ocular adverse events were noticed. CONCLUSION: An initial core vitrectomy combined with a conventional ranibizumab injection regimen for exudative AMD patients was safe and lead to similar functional results with less intravitreal ranibizumab injections over 48 weeks.
RCT Entities:
PURPOSE: To investigate the clinical efficacy and safety of an additional core vitrectomy to the standard therapy in patients with exudative 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 (3x Rbz) and Group 2 - 3x Rbz (control). 1 16 of 25 eyes in Group 1(64%) and 12 of 25 (48%) in Group 2 had a posterior vitreous detachment (PVD) prior to start of the study. Changes in best-corrected visual acuity (BCVA) using ETDRS charts, central macular thickness and macular volume (OCT) as well as the rate of reinjection with an OCT-based pro renata (PRN) protocol were monitored prospectively over 48 weeks. Forty-seven eyes completed follow-up at week 48. RESULTS: In Group 1, 4 of 24 lost 1 line of BCVA (16.7%) and 3 of 24 lost 2 lines (12.5%), whereas 17 of 24 gained more than 1 line (70.8%) and improved in average by 9.8 letters. In Group 2, 3 of 23 remained stable and 20 of 23 gained more than or exactly 1 line (78.3%), resulting in 14.3 letters, with no loss of lines. Central macular thickness decreased by 85.58 μm (28.8%) in Group 1 and by 121.43 μm (32.68%) in Group 2 compared with 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 4.17 in Group 2 over 48 weeks. Posterior vitreous detachment (PVD) was identified in Group 1 in 16 of 24 (66.7%) and in Group 2 in 12 of 23 (52.2%) patients at baseline. At week 48, 6 of 8 (75%) of the patients in Group 1 with initial attached vitreous showed a vitreal detachment, whereas only 1 of 11 (9%) in Group 2 had a new occurred detachment of the vitreous. No systemic or ocular adverse events were noticed. CONCLUSION: An initial core vitrectomy combined with a conventional ranibizumab injection regimen for exudative AMDpatients was safe and lead to similar functional results with less intravitreal ranibizumab injections over 48 weeks.