Short-term efficacy and safety of intravitreal brolucizumab in diabetic macular edema: A retrospective interventional study.

Abstract

Objectives: This study aims to evaluate the efficacy and safety of intravitreal brolucizumab (IVBr), a novel antivascular endothelial growth factor agent, in the treatment of diabetic macular edema (DME) by assessing both functional (visual) and structural (anatomical) improvements.

Materials and methods: A retrospective, interventional study was conducted at the ophthalmology outpatient department of Sultan Qaboos University Hospital at University Medical City. A cohort of twenty patients (60 injections) with DME received three IVBr injections (6 mg/0.05 mL) over 18 weeks. This cohort consists of 10 male and 10 female patients, with a mean age of 57.1 years (range: 35-81; standard deviation [SD] 14.37). The best-corrected visual acuity (BCVA) was measured and recorded in equivalent logMAR. The subfoveal macular thickness (SFMT) was assessed with optical coherence tomography. Statistical analysis was carried out using paired t-test, and 95% confidence intervals were calculated to compare changes in outcomes, with a significance threshold set at P < 0.05.

Results: The BCVA improved significantly from a baseline mean of logMar 0.36 (SD 0.7) to 0.22 (SD 0.5) after the third injection (P < 0.002). SFMT decreased from a mean of 517.75 μm (SD 160.27) to 287.95 μm (SD 101.31), P < 0.001. One patient developed intraocular inflammation, and no other major complications were observed. However, 35% of patients (n = 7) experienced inadequate visual improvement, attributed to underlying factors such as macular ischemia, retinal layer disorganization, disruption of the ellipsoid zone, and residual macular edema.

Conclusion: The study findings in this cohort demonstrated statistically significant improvement in BCVA and a substantial decrease in SFMT. However, more real-world studies are required to enhance the validation of this study's findings.