PURPOSE: To determine whether combined intravitreal bevacizumab (IVB) and triamcinolone (IVT) is more effective than IVB alone in neovascular age-related macular degeneration. METHODS: This was a prospective, randomized clinical trial performed at two centers. Eligible eyes were assigned randomly to one of the two study arms. In the IVB group, 3 consecutive injections of 1.25 mg of bevacizumab were given 6 weeks apart, while in the IVB/IVT group, the first of the triple IVB injections was combined with 2 mg of IVB. A fourth IVB was injected in eyes demonstrating active choroidal neovascularization at Week 24. RESULTS: Sixty and 55 eyes were in the IVB and IVB/IVT groups, respectively. Best-corrected visual acuity improved, and central macular thickness was reduced significantly in both groups at all time points. Visual improvement was more pronounced in the IVB/IVT group compared with the IVB group 6 weeks (8.5 ± 14.4 vs. 3.8 ± 8.9 letters, P = 0.04) and 12 weeks (11.8 ± 16.6 vs. 6.2 ± 10.8 letters, P = 0.03) after initiation of therapy. However, there was no significant difference in visual improvement at Week 24 (11.3 ± 17.2 letters in the IVB/IVT group vs. 8.7 ± 15.6 letters in the IVB group, P = 0.40). The IVB/IVT group showed significantly less need for a fourth injection at Week 24 (34.5% vs. 53.3% in the IVB/IVT and IVB groups, respectively, P = 0.04). CONCLUSION: Mandated therapy with IVB improved best-corrected visual acuity and decreased central macular thickness in neovascular age-related macular degeneration. The addition of low-dose IVT temporarily increased the therapeutic efficacy in the early postinjection period and resulted in fewer requirements for repeat IVB injections at 6 months; however, final levels of visual improvement were comparable in the 2 study groups.
RCT Entities:
PURPOSE: To determine whether combined intravitreal bevacizumab (IVB) and triamcinolone (IVT) is more effective than IVB alone in neovascular age-related macular degeneration. METHODS: This was a prospective, randomized clinical trial performed at two centers. Eligible eyes were assigned randomly to one of the two study arms. In the IVB group, 3 consecutive injections of 1.25 mg of bevacizumab were given 6 weeks apart, while in the IVB/IVT group, the first of the triple IVB injections was combined with 2 mg of IVB. A fourth IVB was injected in eyes demonstrating active choroidal neovascularization at Week 24. RESULTS: Sixty and 55 eyes were in the IVB and IVB/IVT groups, respectively. Best-corrected visual acuity improved, and central macular thickness was reduced significantly in both groups at all time points. Visual improvement was more pronounced in the IVB/IVT group compared with the IVB group 6 weeks (8.5 ± 14.4 vs. 3.8 ± 8.9 letters, P = 0.04) and 12 weeks (11.8 ± 16.6 vs. 6.2 ± 10.8 letters, P = 0.03) after initiation of therapy. However, there was no significant difference in visual improvement at Week 24 (11.3 ± 17.2 letters in the IVB/IVT group vs. 8.7 ± 15.6 letters in the IVB group, P = 0.40). The IVB/IVT group showed significantly less need for a fourth injection at Week 24 (34.5% vs. 53.3% in the IVB/IVT and IVB groups, respectively, P = 0.04). CONCLUSION: Mandated therapy with IVB improved best-corrected visual acuity and decreased central macular thickness in neovascular age-related macular degeneration. The addition of low-dose IVT temporarily increased the therapeutic efficacy in the early postinjection period and resulted in fewer requirements for repeat IVB injections at 6 months; however, final levels of visual improvement were comparable in the 2 study groups.
Authors: Carl B Rebhun; Eric M Moult; Stefan B Ploner; Carlos Moreira Neto; A Yasin Alibhai; Julia Schottenhamml; Byungkun Lee; WooJhon Choi; Fareed A Rifai; Mary W Tam; Lennart Husvogt; Caroline R Baumal; Andre J Witkin; Andreas Maier; Philip J Rosenfeld; Jay S Duker; James G Fujimoto; Nadia K Waheed Journal: Ophthalmol Retina Date: 2017-10-31
Authors: Bozho Todorich; Aristomenis Thanos; Yoshihiro Yonekawa; Gerta Mane; Madeleine Hasbrook; Benjamin J Thomas; Maria A Woodward; George A Williams; Antonio Capone; Jeremy D Wolfe; Lisa J Faia; Tarek S Hassan Journal: J Vitreoretin Dis Date: 2017-01-26