Purpose We report the 3-month efficacy of monthly intravitreal ziv-aflibercept in patients with diabetic macular oedema (DME).
Methods Prospectively, consecutive patients with DME underwent intravitreal injection of 0.05 ml of compounded ziv-aflibercept (1.25 mg) from March 2015 to November 2015. Monitoring of best-corrected visual acuity (BCVA), intraocular inflammation, cataract progression and retinal structure by spectral domain optical coherence tomography was carried out at baseline, 1 week, 1 month, 2 months and 3 months after 3 monthly injections.
Results A total of 17 eyes (11 right eyes and 6 left eyes) were treated. The participants were divided into 10 Caucasians and 6 Indians, 11 men and 5 women, and had a mean age of 61.5 years. Five eyes were treatment-naïve cases and 12 eyes were treatment non- naïve with last treatment received at least more than 4-month interval. Mean BCVA in log MAR (equivalent Snellen visual acuity) improved from baseline 0.70 (20/100) to 0.49 (20/60) at 1 month, 0.43 (20/50) at 2 months and 0.42 (20/50) at 3 months (p ≤ 0.003). Central macular thickness decreased from mean baseline 517.5 to 388.1 μm at 1 week, 355.4 μm at 1 month, 351.4 μm at 2 months and 322.2 μm at 3 months (p ≤ 0.001).
Conclusions Off-label use of intravitreal ziv-aflibercept improves visual acuity, without detectable ocular toxicity or systemic side effects in DME. It offers a less expensive alternative to the approved intravitreal aflibercept (Eylea), especially in the low/middle-income countries and in countries where Eylea is not available.
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Contributors Design (AMM, JC) and conduct (AMM, JC) of the study; collection (AMM, JC, CD), management (AMM, JC, CD), analysis (AMM) and interpretation of the data (AMM, JC); and preparation (AMM), review (AMM, JC) or approval (AMM, JC, CD) of the manuscript.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Institutional review board.
Provenance and peer review Not commissioned; externally peer reviewed.