Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study.

Li, Xiaoxin; Dai, Hong; Li, Xiaorong; Han, Mei; Li, Jun; Suhner, Andrea; Lin, Renxin; Wolf, Sebastian (2019). Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study. Graefe's archive for clinical and experimental ophthalmology, 257(3), pp. 529-541. Springer 10.1007/s00417-018-04213-x

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PURPOSE To demonstrate the efficacy and safety of ranibizumab 0.5 mg pro re nata (PRN) versus laser photocoagulation for the treatment of Chinese patients with visual impairment due to diabetic macular edema (DME). METHODS REFINE was a phase III, 12-month, double-masked, multicenter, laser-controlled study in patients (aged ≥ 18 years) with DME. Patients were randomized 4:1 to receive either ranibizumab 0.5 mg or laser dosing regimen. Efficacy was evaluated as mean average change in best-corrected visual acuity (BCVA) from Months 1 to 12 versus baseline (primary endpoint), anatomical outcomes, treatment exposure, and safety were also assessed. RESULTS Ranibizumab was statistically superior (p < 0.001) to laser treatment, with a mean average BCVA gain of 6.8 letters (ranibizumab) over 12 months versus 1.1 letters (laser). At Month 12, mean BCVA gain was 7.8 letters (ranibizumab) and 2.5 letters (laser) from baseline. Patients in the ranibizumab arm received a mean number of 7.9 intravitreal injections, whereas those in the laser arm received a mean of 2.1 treatments. There were no new safety signals. CONCLUSION Ranibizumab 0.5 mg PRN demonstrated a statistically significant and clinically meaningful treatment effect versus laser and was well tolerated in Chinese patients with visual impairment due to DME over 12 months.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology

UniBE Contributor:

Wolf, Sebastian

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0721-832X

Publisher:

Springer

Language:

English

Submitter:

Sebastian Wolf

Date Deposited:

01 Feb 2019 12:48

Last Modified:

01 Mar 2019 01:33

Publisher DOI:

10.1007/s00417-018-04213-x

PubMed ID:

30645696

Uncontrolled Keywords:

Anti-vascular endothelial growth factor Diabetic macular edema Pro re nata Ranibizumab

BORIS DOI:

10.7892/boris.125369

URI:

https://boris.unibe.ch/id/eprint/125369

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