T&E Dosing of intravitreal Aflibercept Improves Macular Edema after central retinal vein occlusion: Study

Previous study findings demonstrated that IVT-AFL was beneficial for the treatment of macular edema secondary to CRVO. However, Post-hoc assessment of the different dosing subgroups demonstrated some de-stabilization of the disease with PRN dosing. Post-hoc analyses of COPERNICUS and GALILEO supported the implementation of proactive treatment to prevent deterioration of functional and anatomic outcomes.

Treat and extend (T&E) is a proactive, individualized dosing strategy whereby the patient receives an injection at every visit. Additionally, with T&E dosing regimens, the need for interim monitoring is minimized, which reduces the number of appointments per patient and minimizes the need for monitoring visits. However, T&E dosing regimens have not been evaluated in large-scale studies of IVT-AFL for the treatment of macular edema secondary to CRVO. Therefore, Dr Jean-François Korobelnik and team conducted a study to assess the efficacy and safety of IVT-AFL administered in a T&E dosing regimen in patients with macular edema secondary to CRVO.

CENTERA was an open-label, multicentric, Phase 4 clinical study of 162 patients with centre-involved macular edema secondary to CRVO for no longer than 3months. It was a single-arm study in which patients received 2mg IVT-AFL at baseline and every 4weeks (wks) until disease stability criteria were met (or until Wk20), at which point treatment intervals were adjusted in 2-wk increments based on functional and anatomic outcomes.

Key findings of the study were:

• From baseline to Week 76, researchers found that about 65.6% of patients gained ≥15 letters.

• In the T&E phase, they noted that about 45.0% of patients achieved a mean treatment interval of ≥8 weeks.

• They also noted that the last and next planned treatment interval of ≥8 wks was achieved by 63.1% (n=101) and 67.5% (n=108) of patients, respectively.

• They found that the mean best-corrected visual acuity increased from 51.9 letters at baseline to 72.3 letters at Week 76 (mean change: +20.3 letters).

• They also found that the mean central retinal thickness decreased from 759.9 µm at baseline to 265.4 µm at Week 76 (mean change: −496.1 µm).

The authors concluded, "Clinically meaningful improvements in functional and anatomic outcomes were achieved with IVT-AFL T&E dosing. Most patients achieved a last actual and last intended treatment interval of ≥8 wks, therefore treatment intervals may have been extended even further with a longer study duration."

For further information:

https://www.ajo.com/article/S0002-9394(21)00058-1/fulltext