The Comparison of Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis)with Imported Ranibizumab (Lucentis) in Patients with Diabetic Macular Edema: Double-blind Noninferiority Clinical Randomized Trial
Mehdi Modarreszadeh1 *, hoshang faghihi2 , ahad sedaghat3 , nazanin adidi aghdam2 , Hamid Riazi Esfahani 2 , pasha anvari1 , fatemeh abdi1 , reza mirshahi1 , fatemeh bazvand2 , sayyed amirpooya Alemzadeh1
- Eye Research Center, The Five Senses Institute Rassoul Akram Hospital , Iran University of Medical Sciences, Tehran, Iran
- Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
- Eye Research Center, The Five Senses Health Institute, Rassoul Akram Hospital , Iran University, of Medical Sciences, Tehran, Iran
Abstract: The Comparison of Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis)with Imported Ranibizumab (Lucentis) in Patients with Diabetic Macular Edema: Double-blind Noninferiority Clinical Randomized Trial
Methods: The trial has a parallel-arm design.
Eligible participants with type 1 or type 2 diabetes mellitus, at least 18 years old
The primary outcome measures
changes in CMT compared to the baseline. The central macular thickness will define by the average thickness of a central macular region 1,000 μm in diameter centered on the patient’s foveola.
Secondary outcome measures include a change in best-corrected logMAR visual acuity, complication includes IOP rise, cataract progression, intraocular inflammation, and any other serious adverse effect.
First arm: An Intravitreal injection of 0.5mL (400μg) of Ranibizumab (Visentis, Iranian made)
Second arm: An intravitreal injection of Ranibizumab of 0.5mL (400μg) (Lucentis)
Group sample sizes of 77 and 77 achieve 90% power to detect non-inferiority using a one-sided, two-sample t-test. The margin of non-inferiority is 40.00 μm
Results: Till now 130 patients were recruited and we report the outcome of 95 patients with a one-month follow-up.
The mean age of patients was 60.01? 8.62 years. The youngest one was 36 and the oldest was 75 years old.
The mean age in group A was 59.77?8.31 and in the group, B was 59.43? 9.01.
The central macular thickness in group A decreased from 496.81 ? 136.75?m to 378.76 ? 95.19?m (P<0.001).
The central macular thickness in group B decreased significantly from505.70 ? 164.65?m to378.17 ? 114.18 ?m (P<0.001).
The between-group analysis showed no significant differences. (P>0.05)
Mean Visual Acuity in Group A from0.64 ? 0.28 LogMAR in baseline decreased significantly to 0.53 ? 0.30 LogMAR (P=0.001).
Mean Visual Acuity in Group B from 0.56 ? 0.27 LogMAR in baseline decreased to 0.47 ? 0.26 LogMAR (P=0.01).
The between-group analysis showed no significant differences. (P>0.05).
The point estimate of the mean CMT difference between groups was -9.35?m before imputation and -7.21?m after imputation (cf 95% -55-41?m).
No serious adverse effect was reported.
Conclusion: One intravitreal injection of Iranian made ranibizumab was found to be safe and effective to original medication
