Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusionin Chinese patients: randomized, sham-controlled, multicenter study
Xiaoxin Li, Ningli Wang, Xiaoling Liang, Gezhi Xu, Xiao-yan Li, Jenny Jiao, Jean Lou, Yehia Hashad, China Ozurdexin RVO Study Group
Published 2018-05-25
Cite as Chin J Ocul Fundus Dis, 2018, 34(3): 212-220. DOI: 10.3760/cma.j.issn.1005-1015.2018.03.003
Abstract
ObjectiveTo evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg(DEX) for treatment of macular edema associated with retinal vein occlusion (RVO).
MethodsThis study was a six-month, randomized, double-masked, sham-controlled, multicenter, phase 3 clinical trial with a 2-month open-label study extension. Patients with branch or central RVO received DEX (n=129) or sham procedure(n=130) in the study eye at baseline; all patients who met re-treatment criteria received DEX at month 6. Efficacy measures included Early Treatment Diabetic Retinopathy Study (ETDRS), best-corrected visual acuity (BCVA), and central retinal thickness (CRT) on optical coherence tomography.
ResultsTime to ≥15-letter BCVA improvement from baseline during the first 6 months (primary endpoint) was earlier with DEX than sham (P<0.001). At month 2 (peak effect), the percentage of patients with ≥15-letter BCVA improvement from baseline was DEX: 34.9%, sham: 11.5%; mean BCVA change from baseline was DEX: 10.6±10.4 letters, sham: 1.7±12.3 letters; and mean CRT change from baseline was DEX: −407±212 μm, sham: −62±224 μm (all P<0.001). Outcomes were better with DEX than sham in both branch and central RVO. The most common treatment-emergent adverse event was in-creased intraocular pressure (IOP). Increase sin IOP generally were controlled with topical medication. Mean IOP normalized by month 4, and no patient required incisional glaucoma surgery.
ConclusionsDEX had a favorable safety profile and provided clinically significant benefit in a Chinese patient population with RVO. Visual and anatomic outcomes were improved with DEX relative to sham for 3- 4 months after a single implant.
Key words:
Corticosteroids; Drug delivery systems; Intravitreal injections; Macular edema; Retinal vein occlusion; Randomized controlled trial
Contributor Information
Xiaoxin Li
Department of Ophthalmology, Peking University People's Hospital
Key Laboratory of Vision Loss and Restoration, Ministry of Education, Beijing 100044, China
Ningli Wang
Beijing Tongren Eye Center, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
Xiaoling Liang
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangzhou 510060, China
Gezhi Xu
Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China
Xiao-yan Li
Allergan plc, Irvine, CA, USA
Jenny Jiao
Allergan plc, Irvine, CA, USA
Jean Lou
Allergan plc, Irvine, CA, USA
Yehia Hashad
Allergan plc, Irvine, CA, USA
China Ozurdexin RVO Study Group
