Patients with DME achieve long-term clinical improvement with intravitreal aflibercept
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Key takeaways:
- Both treatment-naïve and previously treated patients with DME achieved improvements in visual acuity and central retinal thickness.
- The safety profile of intravitreal aflibercept was similar to previous studies.
Patients with diabetic macular edema treated with intravitreal aflibercept for up to 24 months achieved functional and anatomical improvements, even with reduced injection frequency, according to study results in Ophthalmology and Therapy.
“Diabetic macular edema is a leading cause of vision loss in patients with diabetes, with approximately 5.5% of all patients clinically diagnosed with this retinal disease worldwide,” Simone Donati, MD, from the University of Insubria in Italy, and colleagues wrote. “The global prevalence of DME is rising, which is associated with the increasing prevalence of type 2 diabetes mellitus.”
Although intravitreal aflibercept, an anti-VEGF agent, has been approved by the FDA and European Medicines Agency for the treatment of visual impairment from DME, real-world data about its long-term effectiveness and safety are lacking.
Donati and colleagues conducted the 24-month prospective, observational AURIGA study at 243 clinical settings across 11 countries to evaluate long-term outcomes of intravitreal aflibercept (IVT-AFL) among 1,478 treatment-naïve and 384 previously treated patients with DME. The primary study endpoint was mean change in visual acuity from baseline to month 12.
According to results, the mean number of IVT-AFL treatments received by months 6, 12 and 24 was similar among the two cohorts (3.8, 4.9 and 5.7, respectively, in treatment-naïve group and 3.9, 4.9 and 6.2 in the previously treated group). Researchers noted that most participants (86%) in the treatment-naïve group did not receive all five initial monthly doses.
The mean change in visual acuity from baseline to month 12 was +6.7 letters in the treatment-naïve group and +7.4 letters in the previously treated group, and +5.9 and +8.1 letters, respectively, at month 24.
Researchers reported that nearly 26% of those in the treatment-naïve group achieved at least 15-letter gains by month 24, as did nearly 33% of previously treated patients.
The mean change in central retinal thickness from baseline to month 24 was –110 µm in the treatment-naïve group and –169 µm in the previously treated group.
Further, the safety profile of IVT-AFL was similar to that reported in previous studies, with one case of uveitis in the treatment-naïve group and one case of endophthalmitis in the previously treated group, both of which were considered serious and treatment-related. The most common treatment-emergent adverse events among both cohorts were conjunctival hemorrhage, cataract and epiretinal membrane.
“In AURIGA, treatment-naïve and previously treated patients with DME achieved clinically relevant functional and anatomic improvements following IVT-AFL treatment for up to 24 months in routine clinical practice,” Donati and colleagues wrote. “Even with the decreasing injection frequency observed, these gains were largely maintained throughout the study, suggesting long-term durability of the positive effects of IVT-AFL treatment.”
Perspective
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This study is a prospective observational study that evaluates intravitreal aflibercept (IVT-AFL) in the treatment of diabetic macular edema or macular edema secondary to retinal vein occlusion in routine clinical practice.
Patients were enrolled from 11 different countries, both with and without a history of previous treatment, which allowed for a nice heterogenous patient cohort. The study found clinically relevant functional and anatomic improvements following IVT-AFL treatment, which was performed up to 24 months.
Improved visual acuity was reported within 6 months of IVT-AFL treatment in both study groups, and by the end of the study period, up to one in four patients from the treatment-naïve group and one in three patients with previous treatment history achieved 15 letters or more improvement in visual acuity, measured using Early Treatment Diabetic Retinopathy Study chart.
A great strength for this study is the large sample size — 1,478 patients without any previous treatment and 384 patients with previous treatment for DME. However, a big limitation was that treatment was provided based at the discretion of the attending physician in differing types of clinical practice.
The study was observational in nature and the lack of consistency in recommending treatment can certainly affect overall results. Other major points of concern include the varied frequency of patient visits between the countries, including total treatment time, and various methodologies for testing and collecting data from the various clinical sites.
While the findings from this study are promising, the underlying methodological inconsistencies may limit the clinical relevance of the overall results and conclusions. A randomized clinical trial with standardization across all study sites would be key to getting a better understanding of outcomes with IVT-AFL treatment.
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