scholarly journals Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis

2018 ◽  
Vol Volume 12 ◽  
pp. 2519-2534 ◽  
Author(s):  
Adnan Tufail ◽  
Sue Lightman ◽  
Ahmed Kamal ◽  
Uwe Pleyer ◽  
Nuria María Gajate Paniagua ◽  
...  
2018 ◽  
Vol 171 ◽  
pp. 174-182 ◽  
Author(s):  
Lasse Jørgensen Cehofski ◽  
Anders Kruse ◽  
Sigriður Olga Magnusdottir ◽  
Alexander Nørgård Alsing ◽  
Jonas Ellegaard Nielsen ◽  
...  

2018 ◽  
Vol 28 (6) ◽  
pp. 697-705 ◽  
Author(s):  
Francesco Bandello ◽  
Albert Augustin ◽  
Adnan Tufail ◽  
Richard Leaback

Purpose: Dexamethasone intravitreal implant and intravitreal ranibizumab are indicated for the treatment of macular edema secondary to retinal vein occlusion. This non-inferiority study compared dexamethasone with ranibizumab in patients with branch retinal vein occlusion. Methods: In this randomized, 12-month head-to-head comparison, subjects with branch retinal vein occlusion were assigned to dexamethasone 0.7 mg at day 1 and month 5 with the option of retreatment at month 10 or 11, or ranibizumab 0.5 mg at day 1 and monthly through month 5 with subsequent as-needed injections at month 6–month 11. The primary efficacy outcome was the mean change from baseline in best-corrected visual acuity at month 12; secondary outcomes included average change in best-corrected visual acuity, proportion of eyes with ≥10- and ≥15-letter gain/loss, change in central retinal thickness, and change in Vision Functioning Questionnaire-25 score. Results: In all, 307 of a planned 400 patients were enrolled in the study and received (mean) 2.5 dexamethasone injections (n = 154) and 8.0 ranibizumab injections (n = 153) over 12 months. The mean change from baseline in best-corrected visual acuity at month 12 was 7.4 letters for dexamethasone versus 17.4 letters for ranibizumab (least-squares mean difference (dexamethasone minus ranibizumab), −10.1 letters; 95% confidence interval, −12.9, −7.2; p = 0.0006). Conclusion: Dexamethasone and ranibizumab improved best-corrected visual acuity and anatomical outcomes; however, dexamethasone did not show non-inferiority to ranibizumab in this under-powered study. Dexamethasone was associated with an increased risk of intraocular pressure elevation and cataract progression, but a lower injection burden, compared to ranibizumab.


Ophthalmology ◽  
2010 ◽  
Vol 117 (6) ◽  
pp. 1134-1146.e3 ◽  
Author(s):  
Julia A. Haller ◽  
Francesco Bandello ◽  
Rubens Belfort ◽  
Mark S. Blumenkranz ◽  
Mark Gillies ◽  
...  

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