Greater Functional Outcomes for DME Seen with Aflibercept, Focal/Grid Photocoagulation Treatment

Jakob Grauslund, MD, PhD, DMSci

New findings suggest patients with diabetic macular edema (DME) undergoing combined treatment with intravitreal aflibercept and postloading focal/grid photocoagulation were linked to better functional outcomes compared to a matched, real-world population obtaining standard of care.

Data show the study group achieved these better functional outcomes with 25% fewer injections, with a larger population of the eyes in the study group requiring no extra injections following the loading phase.

“As frequent injections with anti-VEGF agents can be a burden to the patients and expensive to  the  healthcare system, the advantage of combining anti-VEGF therapy with laser therapy might be found in the potential to reduce the numbers of injections while obtaining an equally good visual outcome,” wrote study author Jakob Grauslund, MD, PhD, DMSci, Department of Ophthalmology, Odense University Hospital.

The study investigators recently conducted the 12-month randomized controlled trial ADDEN-DUM, finding a mean of 4.4 intravitreal injections of aflibercept with patients gaining 8.4 Early Treatment Diabetic Retinopathy (ETDRS) letters in best corrected visual acuity (BCVA).

The study did not meet the primary endpoint of better clinical outcomes for those treated with navigated focal/grid photocoagulation, but indicated that with proper timing and combined with aflibercept, the need for intravitreal therapy may be less than traditionally reported.

The principal measurements for the study population from ADDEN-DUM at 12 months were numbers of intravitreal injections, BCVA, and central retinal thickness (CRT). After exclusions, a total of 43 eyes of 32 patients from the study group and 46 eyes from 38 patients were included as the real-world population.

Investigators observed no differences between groups regarding age, sex, body mass index (BMI), hemoglobin A1c (HbA1c), systolic blood pressure or type of diabetes. However, the study population had a higher diastolic blood pressure (81.6 vs 72.1 mm Hg; P = .03) and had diabetes for fewer years (12.3 vs 23.2 years; P = .03).

They further found patients in the study group had received fewer intravitreal aflibercept injections (4.4 vs 5.9; P <.01) and were more likely only to have received the 3 mandatory injections in the loading phase (39.5% vs 13.0%; P = .01).

Then, at month 12, eyes in the study group had a higher BCVA than the eyes in the real-world group (79.6 vs 74.3 ETDRS letters; P = .03). Yet, the change from baseline to follow-up did not differ statistically, according to investigators (+8.4 vs +5.8 ETDRS; P = .19).

Investigators saw no differences in CRT between the 2 groups at baseline (290.5 vs 291.9 µm, P = .31), with similar developments during follow-up (-97.4 vs -103.7 µm, P = .78).

"Studies with longer follow-up times are needed to investigate potential long-term cost–benefits of using fewer intravitreal anti-VEGF injections than in similar studies published so far,” Grauslund concluded. “Future studies also need to address combination therapy with different timings of photocoagulation therapy versus anti-VEGF monotherapy in a randomized controlled setting during more than 12 months.”

The study, “Functional and structural efficacy of a novel combinational therapy of aflibercept and timely focal/grid photocoagulation in diabetic macular oedema: do clinical study results compare favourably with a standard-of-care treated real-world population?,” was published in Acta Ophthalmologica.