Comparative Clinical Outcomes of Intravitreal Aflibercept and Ranibizumab in Patients with Diabetic Macular Edema

Abstract

Objective: To compare one-year visual and anatomical outcomes after intravitreal aflibercept and ranibizumab in treatment-naïve eyes with center-involving diabetic macular edema (DME) at three tertiary eye centers in Punjab, Pakistan.

Methods: This multicenter comparative cohort included 120 patients, with one study eye per patient and 60 patients in each treatment group. Patients received aflibercept 2 mg or ranibizumab 0.5 mg according to the treating specialist’s decision. Three initial monthly injections were followed by monthly assessment and treatment when indicated. Best-corrected visual acuity (BCVA), expressed in Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and optical coherence tomography central subfield thickness (CST) were assessed through month 12. The primary outcome was change in BCVA at one year.

Results: One-year measurements were available for 108 patients, 54 in each group. Mean BCVA increased by 11.3 letters with aflibercept and 9.6 letters with ranibizumab. The between-group difference in mean gain was 1.7 letters (95% confidence interval [CI] −1.9 to 5.3). Mean CST decreased by 151 µm and 130 µm, respectively. At least 10 letters were gained by 28/54 aflibercept-treated eyes (51.9%) and 24/54 ranibizumab-treated eyes (44.4%). Injection numbers were similar. No endophthalmitis was recorded.

Conclusion: Both agents were associated with meaningful improvement in vision and retinal thickness at one year. The study was too small to establish a reliable difference between them. Treatment continuity and baseline vision remained important when interpreting outcomes.