Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema

Area of Science:

• Ophthalmology
• Retinal Diseases
• Pharmacological Interventions

Background:

• Diabetic macular edema (DME) is a leading cause of vision loss in diabetic patients.
• The optimal treatment strategy for DME, comparing aflibercept monotherapy to a step-therapy approach with bevacizumab followed by aflibercept, remains unclear.

Purpose of the Study:

• To compare the relative efficacy of aflibercept monotherapy versus a step-therapy approach using bevacizumab initially, with a switch to aflibercept if needed, for treating DME.
• To evaluate visual acuity, retinal thickness, and safety outcomes over a two-year period.

Main Methods:

• A randomized clinical trial involving 312 eyes of 270 adults with center-involved DME.
• Participants received either aflibercept monotherapy or bevacizumab, with a potential switch to aflibercept for suboptimal response.
• Primary outcome was mean change in visual acuity over 2 years; secondary outcomes included retinal thickness and safety.

Main Results:

• No significant difference in mean visual acuity improvement between aflibercept monotherapy (15.0 letters) and bevacizumab-first (14.0 letters) over 2 years.
• Similar changes in visual acuity and central subfield thickness were observed in both groups at 2 years.
• Higher rates of serious adverse events and hospitalizations occurred in the aflibercept monotherapy group.

Conclusions:

• Aflibercept monotherapy and a step-therapy approach with bevacizumab followed by aflibercept demonstrate comparable visual outcomes for DME over two years.
• The bevacizumab-first strategy resulted in fewer serious adverse events and hospitalizations compared to aflibercept monotherapy.