FP1874 : Efficacy & safety of Brolucizumab 6.0 mg versus 3.6 mg in Diabetic Macular Edema

Abstract

Purpose: The dose of Brolucizumab recommended for AMD is 6.0 mg. Ranibizumab hasapproved dose of 0.5 mg for AMD & 0.3 mg for DME.(As a corollary, the equivalent dose of Brolucizumab for DME is 3.6 mg.

Method: Pilot Randomized Control Study. Gp 1 (6.0 mg) and Gp 2 (3.6 mg). The BCVA, CMT on OCT Macula and any adverse effects were observed. At 28th day review a decision on reinjection was taken. Four weekly follow up till mandatory 26 weeks.

Results: N=86 with 44 patients in Gp 1 (received 149 injections) and 42 patients in Gp 2 (received 154 injections). The BCVA improvement and CMT reduction was statistically significant in both the groups. No statistically significant difference in re-injection rates between the two gp. The rate of Grade III adverse events in Gp 1 was 0.67% and in Gp 2 was 0.65%. No Grade IV adverse events occurred.

Conclusion: Brolucizumab 3.6 mg is as efficacious as 6.0 mg dose in managing DME without any serious adverse effects at either dosage.

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