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.