Small Proportion of Patients with MEfCRVO Showed Poor Response After Aflibercept

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Data suggest baseline vision was a key predictor of poor response at Week 24 in patients with macular edema secondary to central retinal vein occlusion.

New findings from a post-hoc analysis of the COPERNICUS and GALILEO trials suggest a small proportion of patients with macular edema secondary to central retinal vein occlusion (MEfCRVO) had a poor response to intravitreal aflibercept injection after 24 weeks.

It was additionally noted that these patients had smaller best corrected visual acuity (BCVA) gains at week 52, despite similar reductions in central subfield thickness (CST) and receiving more pro-re-nata (PRN) dosing.

“Baseline vision was a key predictor of poor response at Week 24,” wrote study author Carmelina Gordon, MD, Specialty Eye Institute.

These findings were presented at the Association of Research in Vision and Ophthalmology (ARVO) 2022 Meeting in Denver, Colorado.

Findings from the phase 3 COPERNICUS and GALILEO demonstrated improved vision and antomatcal outcomes with intravitreal aflibercept injection in patients with MEfCRVO.

Gordon and colleagues aimed to characterize poor response to aflibercept following 24-week treatment, evaluate long-term visual and anatomic outcomes through week 52, and identify baseline factors associated with poor response in this patient population.

Each patient received aflibercept 2 mg every 4 weeks for 24 weeks followed by PRN dosing from Week 24 through Week 52 in COPERNICUS and GALILEO. Investigators defined poor response at week 24 as a combination of visual acuity (<58 letters [Snellen <20/80] or ≤5 letter gain from baseline) and anatomic criteria (CST ≥300 µm or presence of intraretinal or subretinal fluid). All others were considered responders.

Then, univariate analysis examined baseline factors associated with poor response, including sex, ethnicity, race, age, BMI, perfusion status, time since diagnosis, BCVA, and CST.

A total of 217 patients who were treated with intravitreal aflibercept injection were considered eligible for the study. Of that number, 18 (8.3%) were poor responders, 184 (84.8%) were responders, and 15 (6.9%) were indeterminate at Week 24.

The baseline characteristics were found comparable between each group, but investigators observed a lower mean BCVA for poor responders compared to responders (42.1 vs 52.7; P = .0145). Further, poor responders received more PRN injections through Week 52 (4.2 vs 2.5; P <.05).

The mean difference (95% confidence interval [CI]) in absolute BCVA between poor responders and responders was -23.3 (95% CI, -30.2 to -16.4) letters at Week 24 and -22.3 (95% CI, -29.8 to -14.8) letters at Week 52.

Moreover, a lower proportion of poor responders vs responders had a gain of ≥5 letters (61.1% vs 88.6%), ≥10 letters (50.0% vs 81.1%), and ≥15 letters (16.7% vs 66.9%) at Week 52.

They found the mean difference in absolute CST between poor responders to be 77.7 µm (95% CI, 24.3 - 131.1) at Week 24 and 40.7 µm (95% CI, -12.8 to 94.2) at Week 52.

“The odds of having a poor response at Week 24 decreased by 21% for every 5-letter increase in baseline BCVA (P=0.0062),” Gordon concluded.

The study, “Poor response to anti-VEGF treatment in macular edema secondary to central retinal vein occlusion and its baseline predictors: a post hoc analysis of COPERNICUS and GALILEO,” was presented at ARVO 2022.