A new study supports an individualized treatment plan for aflibercept, showing its improved efficacy with fewer injections over 2 years.
A novel, individualized treatment protocol for 2 mg aflibercept was associated with improved long-term visual outcomes in treatment-naïve branch retinal vein occlusion (BRVO) patients with macular edema, according to new trial data.1
In research from a team of Japan ophthalmology investigators, the anti-VEGF injection therapy aflibercept was optimal in improving best corrected visual acuity (BCVA) over 2 years among BRBO patients with macular edema when administered by an individualized administration based on 2-week progression of patient eye BCVA and central macular thickness (CMT).
The study, led by Hidetaka Noma, of the Department of Ophthalmology at Hachioji Medical Center, Tokyo Medical University, supports advocacy of individualized treatment protocols with anti-VEGFs like aflibercept among treatment-naïve patients with BRVO and macular edema.
Noma and colleagues conducted the 24-month study in order to interpret individualized anti-VEGF intravitreal treatment regimens on the basis of previously supporting research—as well as the need to adequately refine the dosing regimen of costly, sometimes burdensome but altogether efficacious agents like aflibercept.
BRVO, which predominately impacts older adults, requires treatment monitoring per each affected eye.
“Repeated injection of intravitreal anti-VEGF drugs sometimes causes adverse effects, including ocular pain, ischemic retinopathy, and endophthalmitis, and is also expensive,” investigators wrote. “In addition, some patients respond well to treatment whereas others show poor or no treatment response. For this reason, authors have suggested that treatment protocols should be individualized.”
Investigators assessed 48 eligible eyes with BRVO and macular edema in as many patients. Mean duration from first symptoms to first ophthalmological examination was 41.9 days. Patients received an initial aflibercept injection followed by an examination every 2 weeks until edema recurred; they then received a second treatment injection at recurrence.
The team then defined the period of efficacy as the time between first and second aflibercept injections, which was used to establish their personalized treatment interval (1 week shorter than the period of efficacy).
A total of 37 (77.1%) showed recurrence after the first aflibercept injection. Mean period of efficacy among these patients was 92.5 (SD, 40.8) days; mean number of visits before recurrence were 7.6 (SD, 2.9).
Noma and colleagues observed a significantly better mean BCVA score at 24 months versus baseline, but significantly worse than the best BCVA during the period of efficacy. Mean BCVA gain was 0.07 (SD, 0.18) logMAR at 24 months.
Mean 24-month CMT was also significantly lower than mean baseline CMT, but showed no difference from mean best CMT (P = .06). Mean total visits per patient over 24 months was 15.8 (SD, 3.4).
Investigators noted that the mean 2-year gain in BCVA was similar to outcomes of other aflibercept clinical trials over such a duration; however, their patients’ mean 7.2 injections during that time period was less than such other trials.
“Unclear is whether several continuous monthly injections are required as a treatment induction phase in every eye with BRVO and macular edema,” they noted. “In clinical practice, we sometimes encounter patients with BRVO and macular edema who achieve complete resolution of macular edema with a single injection of an anti-VEGF drug.”
Though some limitations of the trial include a shortened preclinical period and a relatively small participant eye pool, the investigators concluded this novel individualized protocol may be useful, effective and noninferior standard aflibercept treatment protocol for the in-need patient population.
“Thus, individualized protocols should be considered for the treatment of macular edema associated with BRVO,” they wrote.