Alan Berger1, Tom Sheidow2, Alan F Cruess3, Jean Daniel Arbour4, Anne-Sophie Courseau5, Frederica de Takacsy5. 1. St. Michael's Hospital, Toronto. 2. Ivey Eye Institute, St. Joseph's Hospital, London, Ont. Electronic address: Sheidowt@me.com. 3. Dalhousie University, Halifax, N.S. 4. CHUM, Notre-Dame Hospital & University of Montreal, Montreal. 5. Novartis Pharmaceuticals, Dorval, Que.
Abstract
OBJECTIVE: To compare the efficacy and safety of ranibizumab 0.5 mg intravitreal injection, as monotherapy or in combination with laser, with laser monotherapy in patients with visual impairment caused by diabetic macular edema. DESIGN: Twelve-month, multicentre, open-label, parallel-group, randomized, active-control study. PARTICIPANTS: A total of 220 (ranibizumab monotherapy: n = 75, ranibizumab + laser: n = 73, laser monotherapy: n = 72) patients with a diagnosis of type I or II diabetes and visual impairment caused by macular edema were included in the efficacy analysis. METHODS:Ranibizumab was initiated with a fixed loading phase of 3 monthly injections followed by as needed therapy until stable vision achievement. Efficacy end points were the change in best corrected visual acuity (BCVA), change in central retinal thickness (CRT) measured by optical coherence tomography, proportion achieving a 15-letter BCVA gain, and 12-month Visual Function Questionnaire-25 (VFQ-25) score. Safety was assessed with the incidence and severity of adverse events. RESULTS: At 12 months, significant (p < 0.001) mean BCVA improvements were observed for both the ranibizumab monotherapy (+8.9 [95% confidence interval (CI) 7.0-10.7] letters) and the ranibizumab + laser (+8.2 [95% CI 6.0-10.4] letters) groups compared with the laser monotherapy group (+0.3 [95% CI -2.9 to 3.5] letters). Similarly, a better response in terms of CRT improvement, BCVA letter gain, and VFQ-25 was observed in both ranibizumab groups compared with laser monotherapy. The safety profile was comparable in the 2 ranibizumab groups. CONCLUSIONS:Ranibizumab as monotherapy or combined with laser resulted in significantly higher improvements in visual acuity and vision-related quality of life at month 12 as compared with laser monotherapy.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of ranibizumab 0.5 mg intravitreal injection, as monotherapy or in combination with laser, with laser monotherapy in patients with visual impairment caused by diabetic macular edema. DESIGN: Twelve-month, multicentre, open-label, parallel-group, randomized, active-control study. PARTICIPANTS: A total of 220 (ranibizumab monotherapy: n = 75, ranibizumab + laser: n = 73, laser monotherapy: n = 72) patients with a diagnosis of type I or II diabetes and visual impairment caused by macular edema were included in the efficacy analysis. METHODS:Ranibizumab was initiated with a fixed loading phase of 3 monthly injections followed by as needed therapy until stable vision achievement. Efficacy end points were the change in best corrected visual acuity (BCVA), change in central retinal thickness (CRT) measured by optical coherence tomography, proportion achieving a 15-letter BCVA gain, and 12-month Visual Function Questionnaire-25 (VFQ-25) score. Safety was assessed with the incidence and severity of adverse events. RESULTS: At 12 months, significant (p < 0.001) mean BCVA improvements were observed for both the ranibizumab monotherapy (+8.9 [95% confidence interval (CI) 7.0-10.7] letters) and the ranibizumab + laser (+8.2 [95% CI 6.0-10.4] letters) groups compared with the laser monotherapy group (+0.3 [95% CI -2.9 to 3.5] letters). Similarly, a better response in terms of CRT improvement, BCVA letter gain, and VFQ-25 was observed in both ranibizumab groups compared with laser monotherapy. The safety profile was comparable in the 2 ranibizumab groups. CONCLUSIONS:Ranibizumab as monotherapy or combined with laser resulted in significantly higher improvements in visual acuity and vision-related quality of life at month 12 as compared with laser monotherapy.
Authors: Eliane C Jorge; Edson N Jorge; Mayra Botelho; Joyce G Farat; Gianni Virgili; Regina El Dib Journal: Cochrane Database Syst Rev Date: 2018-10-15
Authors: Sobha Sivaprasad; Stephane A Regnier; Franck Fajnkuchen; Jonathan Wright; Alan R Berger; Paul Mitchell; Michael Larsen Journal: Adv Ther Date: 2016-03-07 Impact factor: 3.845