First Author: M.Righini Chossegros FRANCE
Co Author(s): J. Courjaret K. Bezirganyan S. Gensollen L. Curel G. Penaranda F. Queguiner
Back to previous
Exudative AMD, a frequent disease related to the population aging, is one of the leading causes of legal blindness and represents today a major public health problem. In the literature few long-term results in real life study (> 5 years) are available for this type of population. We aimed to describe visual acuity (VA) evolution in real life in patients treated for wet age-related macular degeneration (AMD) with ranibizumab intravitreal injections (IVI) using pro re nata (PRN) regimen over a 5-year period.
The studies took place Saint Joseph Hospital Marseille, France: in the ophthalmologic department for IVI, and in outpatient clinic for the follow-up visits (FU).
ELOUAN 1 & 2 are two retrospective, monocentric studies. From August 2011 to August 2013, 144 consecutive patients with exudative AMD treated in real life with IVI of anti-VEGF (ranibizumab) were included. All patients had a PRN regiment with monthly monitoring performed by two retinologists. Patients were seen either during AMD–dedicated consultations (retinologist 1) or during “standard” consultations (retinologist 2). VA was assessed by ETDRS and Snellen equivalent systems. ELOUAN 1: Data were analyzed at baseline, 3, 6, 12, 18, and 24 months. The following parameters were analyzed: number of FU, number of IVI visits, neo-vessel (NV) types, systematic monthly IVI for the first 3 months (induction phase) or not, AMD–dedicated consultations or “standard” consultations. The primary objective was to study changes in VA over time. The secondary objective was to assess whether the number of FU and injection visits throughout follow-up were good predictor of VA evolution over time ELOUAN 2: Long term results (over a 5-year period) were analyzed among a sub-population of 109 patients with the same parameters as ELOUAN 1.
In the studied population (144 patients, mean age =78.6±8.2 years and female prevalence =67.36%), major medical histories were related to weak cardiovascular conditions, usually observed in elderly. ELOUAN 1: analysis over a 2-year period The mean numbers of FU and IVI visits were respectively 9.9±4.8 and 6.7±5.6. The difference in VA between baseline and other FU was significant at 6 months for Snellen (p=0.0009) and ETDRS (p=0.0069). No differences were found between VA evolution in subgroups A (with an induction phase) and B (without an induction phase), except at 6 months. Patients with induction phase had 3.5-times less chance of VA increase (p=0.0050). The initial NV type did not affect AV evolution. AMD-dedicated consultations induced significantly higher ETDRS scores at 4, 6, 8 and 12 months (p<0.05) than standard consultations. ELOUAN2: sub-analysis over a five-year period (109 patients) VA declined from 24 months until the end of the follow-up, but not significantly. The mean number of FU and IVI decreased (mostly significantly) all along the follow-up. These long term results were concording with real life results. No serious adverse events or any complications related to ranibizumab IVI were observed.
The ELOUAN 1 & 2 results pointed out some relevant implications for clinical practice as to the usefulness of monthly FU visits while allowing for an induction phase only when necessary. The 24-month results showed that the absence of 3 systematic IVI monthly during the first 3 months was not a bad prognosis in our study. Moreover, AMD-dedicated consultations were efficient for patients during the first year of the treatment compared to standard consultations. To obtain satisfactory results, patients‘ visits should be carried out in a specialized centre where adapted AMD consultations (with specific schedules and organization) can be implemented. Finally, ranibizumab IVI can be considered as a reliable treatment for exudative AMD, even in the long term (5 years).