Study Shows Complete Polypoidal Regression After Aflibercept Injections

Indocyanine Green Retinal Angiogram Under Infrared Light. (Photo By BSIP/UIG Via Getty Images)
The research shows the effect can occur as early as 2 months after treatment.

In polypoidal choroidal vasculopathy (PCV) cases, complete polypoidal regression can happen by 2 months after aflibercept injections — and most PCV eyes with complete polypoidal regression by 1 year had that regression within the first 6 months, according to a study in Ophthalmology Retina

“These findings support consideration of aflibercept for PCV to achieve both anatomical and visual outcomes,” investigators conclude.

The multicenter prospective study, conducted at 2 university-based centers in Thailand, looked at 40 eyes of 39 adults with treatment-naïve PCV. Of those enrolled, 100% were Thai, 59% were women, with a mean age of 64±8.3 years, and all were followed for 1 year. Patients received fixed-dosing aflibercept injections — 3 monthly then every-8-weeks — or monthly, if fluid persisted on optical coherence tomography (OCT). Photodynamic therapy (PDT) was used if fluid persisted after 6 consecutive injections. Researchers performed indocyanine green angiography (ICG-A) at baseline, then every 8 weeks, with 2 retina specialists reviewing post-treatment ICG-A, categorized by complete regression (complete disappearance of polypoidal lesions), partial regression (reduced in size or number), or no regression. Any disagreements had open adjudications. At baseline, 6-months, and 1-year, VFQ-25 was obtained. 

The main outcome measure was the timing of complete regression in the course of 1 year.

Investigators found that at baseline, 90% of patients had ≥5 polypoidal lesions and 95% received aflibercept monotherapy, with 5% receiving rescue PDT per protocol. 

“Polypoidal status at 1 year were 55% complete, 40% partial, and 5% no regression,” the study shows. “Cumulative rates of complete regression at 2, 4, 6, and 12 months were 28%, 33%, 43%, and 55%. Of 22 eyes with complete regression at 1 year, complete regression was firstly identified at 2, 4, 6, 8, 10, 12 months in 50%, 9%, 18%, 5%, 9%, and 9%, respectively. Cumulative rates of complete regression among these eyes at 2, 6, and 12 months were 50%, 77%, and 100%, respectively.” 

The median duration of complete regression was 3 months (interquartile range: 2 to 6). And the median VA improved from 20/125 (Snellen equivalent) to 20/50, while median VFQ-25 scores improved from 80 to 93 from baseline to 1-year.

The study’s limitations include its small sample size and a “pre-planned interval of ICGA to be no closer than every 8 weeks according to ethical concerns regarding side effects of ICGA, which prevented an evaluation of complete polypoidal regression before 8 weeks,” the report says.. In addition, in this study, researchers did not evaluate all features associated with PCV, including pulsatile polypoidal lesions, choroidal thickness, size of branching choroidal vascular networks, or size of polypoidal lesions.

Disclosure: Some study author(s) declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.  

Reference

Chaikitmongkol V, Upaphong P, Patikulsila D, et al. Timing of complete polypoidal regression following intravitreous aflibercept treatments in polypoidal choroidal vasculopathy. Ophthalmol Retina. Published online March 27, 2021. doi:10.1016/j.oret.2021.03.012.