Time to recurrence in neovascular age-related macular degeneration after ranibizumab treatment: baseline characteristics of treatment-naive patients enrolled in the ORACLE study

Abstract

Purpose : Attempts have been made to individualize ranibizumab treatment using pro re nata and treat-and-extend regimens to fit therapeutic procedures to the rhythm of recurrences of choroidal neovascularization (CNV). The ability to predict the recurrence interval for an individual patient would help in making retreatment decisions in wet age-related macular degeneration (wAMD). ORACLE is an ongoing 24-month, multicenter, observational study, designed to evaluate the time to recurrence of disease activity in newly diagnosed wAMD patients treated with ranibizumab over 2 years. Here we present baseline characteristics of the enrolled population.

Methods : Patients were enrolled at 69 centers across France between March 2014 and July 2015. Consenting adult patients aged ≥ 55 years with treatment-naïve and active subfoveal CNV were included. The decision to retreat was at the investigator’s discretion. The key endpoints of the study are summarized in Table 1.

Results : Of the 746 patients screened, 706 were enrolled into the study. The mean age (± SD) of patients was 80.2 (± 7.4) years, 66.9% were females and 26.1% had bilateral disease. The mean (± SD) time between diagnosis and initiation of the treatment was 3.16 (± 47.3) days. In the majority of patients, the CNV subtype was categorized as occult (52.6%) followed by predominantly classic (32.9%) and classic (14.5%). For the study eye, the mean best corrected visual acuity at baseline was 58.0 (± 16.9) letters and the mean central retinal thickness was 362.1 (± 115) µm. Other baseline ocular characteristics are presented in Table 2. On optical coherence tomographic (OCT) scans, 48.2% (n = 340) patients had Pigment Epithelial Detachments (PED) at baseline with a mean PED height of 218.7 µm (n = 225).

Conclusions : The overall baseline characteristics of the study cohort give insight on the demographics, functional and anatomical parameters of treatment-naïve patients with wAMD. These epidemiological data from the ORACLE study will help to better define the profile of wAMD patients initiating ranibizumab in 2015. This study will further provide data to better predict the need for retreatment with ranibizumab in wAMD.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Table 1: Key endpoints of the ORACLE study

 

Table 2: Other baseline ocular characteristics of wAMD patients in the ORACLE study