Session Title: Free Paper Session 9: AMD III
Session Date/Time: Friday 08/09/2017 | 08:00-09:30
Paper Time: 09:00
Venue: Room 117
First Author: : T.Yin Wong SINGAPORE
Co Author(s): : W. Lee G. Cheung E. Zhang Y. Ogura S. Leal
In the PLANET study, IVT-AFL monotherapy treatment demonstrated substantial visual acuity gains, and adding rescue verteporfin photodynamic therapy (PDT) did not appear to provide additional visual acuity benefits. The purpose of this report is to describe detailed anatomical and morphological outcomes assessed by optical coherence tomography (OCT) measured by reading centre assessment (RCA). Because diagnosis/treatment decisions in the trial were primarily driven by Investigator Assessment (IA), we also compared RCA-evaluated OCT outcomes in the PLANET study with IA.
PLANET was a multi-centre, randomised, double-masked, sham-controlled Phase 3b/4 study of patients aged ≥50 years with active PCV confirmed by ICGA and a best-corrected visual acuity (BCVA) of 73–24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye.
All patients received 3 monthly IVT-AFL 2 mg injections. At Week 12, patients were randomised 1:1 into IVT-AFL plus sham PDT (IVT-AFL monotherapy) or IVT-AFL plus active PDT arms. Patients in both arms who did not qualify for rescue treatment received IVT-AFL 2 mg every 8 weeks (2q8); patients who qualified for rescue treatment received IVT-AFL 2q4 plus sham or active PDT, according to the randomisation arm, until visual and anatomic outcomes allowed for extension of the treatment interval. Primary efficacy endpoint was mean change in BCVA from baseline to week 52. Exploratory endpoints included the proportion of patients with retinal fluid on OCT and the proportion of patients with a pigment epithelial detachment (PED), among others. Both IA and RCA were conducted (PED by RCA only). The frequency and severity of ocular and nonocular adverse events (AEs) were also evaluated.
A total of 318 patients were randomized and treated. Baseline demographics and characteristics were largely similar across treatment arms. At week 12, before any PDT was administered, about three quarters of patients had no subretinal fluid on OCT, without substantial differences between the IVT-AFL monotherapy and IVT-AFL plus active PDT groups: 72.6% vs 78.1%, respectively (per RCA), and 77.1% vs 77.6%, respectively (per IA). At week 52, the proportion of patients with no subretinal fluid was high and also not substantially different between the IVT-AFL monotherapy and IVT-AFL plus active PDT groups: 90.2% vs 86.9% (RCA) and 86.0% vs 87.6% (IA), respectively. The proportion of patients presenting with PED (per RCA) on OCT between the IVT-AFL monotherapy and IVT-AFL plus active PDT groups was similar: 49.7% vs 43.8% at baseline, 17.8% vs 17.5% at week 12, and 2.8% vs 4.6% at week 52. Common ocular AEs included conjunctival haemorrhage (IVT-AFL monotherapy, 5.1%) and dry eye (IVT-AFL plus active PDT, 5.6%).
This new analysis from the PLANET study shows excellent OCT outcomes with IVT-AFL monotherapy, which was not substantially different when PDT was added as a rescue therapy. These OCT outcomes were similar whether evaluated independently by a reading centre or by study investigators, providing support of the visual acuity outcomes in the PLANET study.