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Combination treatment was equal to anti-VEGF monotherapy in functional and structural outcomes in the treatment of macular edema due to BRVO.
The addition of navigated central laser to aflibercept did not lower treatment burden or affect functional or anatomical outcomes in treatment-naive patients with branch retinal vein occlusion (BRVO) with macular edema, according to new findings.
The overall data report a lower than expected retreatment need in both navigated laser and aflibercept and aflibercept monotherapy, at ≤2 injections after the loading phase and 5 injections during complete follow-up, under the given retreatment criteria.
“In theory, combination treatment would unify the prolonged effect of retinal photocoagulation with the superior outcomes of VEGF inhibitory treatment, but we did not detect any advantages of combination treatment in our study,” wrote study author Katrine Hartmund Frederiksen, MD, Department of Ophthalmology, Odense University Hospital.
Although the effectiveness of angiostatic agents in the treatment of macular edema in patients with BRVO is known, the treatment is inconvenient and novel treatment regimens are warranted, according to investigators. The current randomized study aimed to evaluate if combination treatments of navigated central retinal laser and aflibercept reduced the treatment burden while maintaining functional and anatomical efficacy within 12 months.
The eligibility criteria included foveal center-involved macular edema due to BRVO diagnosed ≤6 months prior to study inclusion, best-corrected visual acuity (BCVA) between 35 - 80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at baseline, aged ≥18 years, and central retinal thickness (CRT) measured by Optical Coherence Tomography (OCT) >300 µm in the study eye.
Following exclusions, patients were randomized 1:1 to 3 monthly injections of 2.0 mg aflibercept with (Group A) or without (Group B) navigated central laser, followed by aflibercept as needed from month 4 through 12. All were examined monthly from month 4 through 12 by BCVA, intraocular pressure and OCT and re-treated with aflibercept according to retreatment criteria. At month 12, participants were re-examined by fundus fluorescein angiography (FFA) and microperimetry.
The team of investigators evaluated 41 eyes of 41 patients, with a mean age of 69.6 years and 56% female patients. Data show the affected eyes had a median BCVA of 70.0 letters, a median CRT of 502 µm and a mean retinal sensitivity of 21.3 dB.
They found the percentage of patients needing re-treatment after month 3 was 71% (15 of 21) and 80% (16 of 20) in groups A and B, respectively (P = .72). The mean BCVA at month 12 was 80.7 versus 80.5 ETDRS letters and the mean change in BCVA from baseline through month 12 was 12.8 versus 15.1 ETDRS letters.
Moreover, the mean change in CRT from baseline through month 12 was -195 versus -181 µm, while the change in mean retinal sensitivity was 3.3 versus 4.1 dB (P = .67) in groups A and B, respectively.
“We argue, based on the results of this study, that an as-needed regimen after loading of aflibercept, is effective in the treatment of BRVO with macular edema, with a low VEGF-inhibitory treatment burden and that the addition of laser cannot be demonstrated to be the decisive factor,” Frederiksen concluded.
The study, “Navigated laser and aflibercept versus aflibercept monotherapy in treatment-naive branch retinal vein occlusion: a 12-month randomized trial,” was published in Acta Ophthalmologica.