T&E Dosing of intravitreal Aflibercept Improves Macular Edema after central retinal vein occlusion: Study
Retinal vein occlusion is a common cause of vision loss in patients with chronic macular edema. A recent study suggests that intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) dosing, improves anatomical and functional outcomes in patients with macular edema, secondary to central retinal vein occlusion (CRVO). The research has been published in the AMERICAN JOURNAL OF OPHTHALMOLOGY on February 05, 2021.
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
