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Introduction <p>We evaluated 24-month real-world outcomes of intravitreal aflibercept 2&#xa0;mg for diabetic macular edema (DME) in treatment-naive eyes and eyes previously treated with macular thermal laser photocoagulation.</p> Methods <p>This retrospective observational cohort study analyzed data from a prospectively designed treatment outcomes registry. We described outcomes separately in treatment-naive eyes and eyes previously treated with macular thermal laser photocoagulation, all of which received intravitreal aflibercept 2&#xa0;mg for DME in routine clinical practice. Given the small number of eyes with prior macular laser, findings in this subgroup were considered descriptive and exploratory. The main functional outcome was change in visual acuity (VA) from baseline at 6, 12, and 24&#xa0;months. The main anatomical outcome was change in central subfield thickness (CST) from baseline at the same time points. Secondary outcomes were injection and visit burden, changes in center-involving clinically significant macular edema activity, time to additional macular laser treatment, and ocular adverse events.</p> Results <p>The cohort included 122 eyes from 78 patients: 110 treatment-naive eyes and 12 eyes with prior macular laser. In treatment-naive eyes, mean VA improved from baseline by 5.5, 5.0, and 5.5 letters at 6, 12, and 24&#xa0;months, respectively. Mean CST decreased by 105.9&#xa0;µm, 90.4&#xa0;µm, and 97.1&#xa0;µm, respectively. In eyes with prior macular laser, changes in VA were not statistically significant at any follow-up point. CST decreased significantly at 6&#xa0;months (−36.5&#xa0;µm) and 12&#xa0;months (−37.5&#xa0;µm), but not at 24&#xa0;months (−26.1&#xa0;µm). By month 24, the median number of injections was 12 in treatment-naive eyes and 11 in eyes with prior macular laser. Additional macular laser was rarely needed, and ocular adverse events were rare.</p> Conclusions <p>In routine clinical care, intravitreal aflibercept 2&#xa0;mg for DME was associated with sustained anatomical improvement and modest, largely stable visual gains over 24&#xa0;months, particularly in treatment-naive eyes. These findings support favorable real-world outcomes with aflibercept, although subgroup findings in eyes with prior macular laser should be interpreted cautiously.</p>

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Aflibercept 24-Month Outcomes in Diabetic Macular Edema With and Without Prior Macular Laser Therapy: Data from the Fight Retinal Blindness! Registry

  • 期刊论文

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  • 发表日期：

    2026年7月4日

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  • Luca Timoceanu,
  • Sarah Steinmann,
  • Mark C. Gillies,
  • Daniel Barthelmes

摘要

Introduction

We evaluated 24-month real-world outcomes of intravitreal aflibercept 2 mg for diabetic macular edema (DME) in treatment-naive eyes and eyes previously treated with macular thermal laser photocoagulation.

Methods

This retrospective observational cohort study analyzed data from a prospectively designed treatment outcomes registry. We described outcomes separately in treatment-naive eyes and eyes previously treated with macular thermal laser photocoagulation, all of which received intravitreal aflibercept 2 mg for DME in routine clinical practice. Given the small number of eyes with prior macular laser, findings in this subgroup were considered descriptive and exploratory. The main functional outcome was change in visual acuity (VA) from baseline at 6, 12, and 24 months. The main anatomical outcome was change in central subfield thickness (CST) from baseline at the same time points. Secondary outcomes were injection and visit burden, changes in center-involving clinically significant macular edema activity, time to additional macular laser treatment, and ocular adverse events.

Results

The cohort included 122 eyes from 78 patients: 110 treatment-naive eyes and 12 eyes with prior macular laser. In treatment-naive eyes, mean VA improved from baseline by 5.5, 5.0, and 5.5 letters at 6, 12, and 24 months, respectively. Mean CST decreased by 105.9 µm, 90.4 µm, and 97.1 µm, respectively. In eyes with prior macular laser, changes in VA were not statistically significant at any follow-up point. CST decreased significantly at 6 months (−36.5 µm) and 12 months (−37.5 µm), but not at 24 months (−26.1 µm). By month 24, the median number of injections was 12 in treatment-naive eyes and 11 in eyes with prior macular laser. Additional macular laser was rarely needed, and ocular adverse events were rare.

Conclusions

In routine clinical care, intravitreal aflibercept 2 mg for DME was associated with sustained anatomical improvement and modest, largely stable visual gains over 24 months, particularly in treatment-naive eyes. These findings support favorable real-world outcomes with aflibercept, although subgroup findings in eyes with prior macular laser should be interpreted cautiously.