Comparison of Ranibizumab 0.5 mg Versus 1.0 mg for the Treatment of Patients With Clinically Significant Diabetic Macular Edema: A Randomized, Clinical Trial.
To compare ranibizumab (Lucentis; Genentech, South San Francisco, CA) 0.5 mg and 1.0 mg for the treatment of clinically significant diabetic macular edema (CSDME).



This was a 12-month, prospective, single-masked, randomized clinical trial. Patients with CSDME secondary to diabetic retinopathy were randomized to receive 0.5 mg or 1.0 mg of ranibizumab by intravitreal injection once monthly for 3 months and then once every other month as needed.



Patients received a mean of 6.5 injections in each group during the course of this 12-month study. The mean change in Early Treatment Diabetic Retinopathy Study visual acuity from baseline to month 12 was +3.8 letters in the ranibizumab 0.5-mg group (n = 23) and +7.9 letters in the 1.0-mg group (n = 23; P = .92 vs. 0.5 mg). Central foveal thickness (CFT) significantly decreased from baseline to month 12 in both dose groups.



Treatment of CSDME with ranibizumab resulted in a statistically significant improvement in visual acuity (ranibizumab 1.0 mg) and decrease in CFT and macular volume (ranibizumab 0.5 mg and 1.0 mg) from baseline to 12 months. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:536-543.].
Philip J
PJ
Ferrone
Jonathan
J
Jonisch
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D003930:Diabetic Retinopathy / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069579:Ranibizumab / Q000008:administration & dosage*; D012160:Retina / Q000473:pathology*; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab