Reading Center Assessments Support Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy

Gemmy Chui Ming Cheung, MBBS, FRCOphth

Investigators of the PLANET study found that the addition of photodynamic therapy to intravitreal aflibercept was noninferior to intravitreal aflibercept monotherapy (IAI) in patients with polypoidal choroidal vasculopathy, a type of neovascular age-related macular degeneration.

A poster at the 2018 American Academy of Ophthalmology Annual Meeting in Chicago, IL, presented a new analysis of the PLANET data that compared the reading center-assessed optical coherence tomography outcomes with investigator assessments from the original study.

“Diagnosis/treatment decisions in the PLANET study were primarily driven by investigator assessment. Therefore, it is of value to compare reading center-assessed (RCA) optical coherence tomography (OCT) outcomes with investigator assessment (IA) to further support the overall PLANET results,” wrote poster authors, led by Gemmy Chui Ming Cheung, MBBS, FRCOphth, an associate professor at the Singapore National Eye Center and Singapore Eye Research Institute, Singapore, Taiwan.

The PLANET study was a 96-week, double-masked, sham-controlled, phase 3b/4 study conducted in 62 sites across Asia and Europe. The 318 participants with a PCV diagnosis on indocyanine green angiography had a mean age (SD) of 70.6 (8.2) years, 96 (30.2%) were women, and 152 (47.8%) were Japanese.

During a run-in period of 3 months, participants received intravitreal aflibercept (2 mg) at weeks 0, 4, and 8. At week 12 participants with suboptimal response were randomized to receive either photodynamic therapy (PDT) (n = 161) or sham PDT (n = 157) along with intravitreal aflibercept.

When participants met the requirements for rescue treatment, PDT or sham treatments were given in addition to intravitreal aflibercept every 8 weeks. Patients who did not meet rescue treatment criteria received intravitreal aflibercept (2 mg) every 8 weeks. The 52 weeks of fixed treatment were followed by an optional treat and extend period up to week 96.

The poster data showed that among the small number of patients who received rescue therapy, a higher proportion achieved dry optical coherence tomography in the photodynamic therapy group compared to the sham PDT group.

At week 96, the percentage of participants with dry optical coherence tomography was high as measured by both reading center-assessment and investigator assessment. These numbers were 73.5% versus 70.1% (RCA) and 83.1% versus 81.0% (IA), for IAI monotherapy and IAI with rescue PDT, respectively.

“This exploratory analysis from the PLANET study demonstrated positive OCT outcomes with IAI monotherapy; addition of PDT as a rescue therapy did not substantially affect OCT outcomes,” wrote the authors.

The most frequent reported ocular adverse events were conjunctival hemorrhage (6.4%; IAI monotherapy) and dry eye (6.8%; IAI with rescue PDT).

The authors concluded that the data supported the efficacy of intravitreal aflibercept monotherapy for patients with polypoidal choroidal vasculopathy.

The poster, “Planet Study: Two-Year Anatomic and Morphologic Outcomes With Intravitreal Aflibercept by OCT,” was presented at the 2018 American Academy of Ophthalmology Annual Meeting in Chicago, IL.

The original study, “Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in the PLANET Study,” was published in JAMA Ophthalmology and sponsored by Bayer Pharmaceuticals.