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David Bellocq, Flore De Bats, Philippe Denis, Laurent Kodjikian; REAL Study :Re-treatment Evaluated on visual Acuity for Lucentis°.. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3947. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
The European market authorization (EMA) of LUCENTIS° in the treatment of exudative age related macular degeneration (AMD) recommends a series of monthly injections until the achievement of stable optimum Visual Acuity (VA) for three consecutive months. This pilot study raises the question of the effectiveness of monthly re-injection of LUCENTIS° resulting in VA stability without anatomical recurrence in OCT.
This is a prospective, monocentric and non-randomized trial including naïve patients with exudative AMD. An assessment of VA in ETDRS letters (Le) and an OCT spectral domain were made at the baseline visit and then on a monthly basis. During the loading phase, each patient received a monthly injection of LUCENTIS° over three months, subsequently monthly injections were renewed until absence of exudative anatomical signs on OCT, and the achievement of three successive stable VA results. During the monitoring the re-treatment of patients followed a reactive (PRN) protocol based on VA and OCT.
Twenty-one patients were included between May 2012 and September 2013, with a monitoring average of 11 months. For 15/21 of the patients with an initial VA average of 54Le (20Le-80Le), a gain of 13Le (1Le-30Le) was obtained until absence of exudative signs in OCT. The continuation of injections (0.6 on average) obtained VA stability with an additional mean gain of +1Le (-1Le-4Le) or a mean gain of 14 Le (1Le-30Le) compared to initial VA. During the maintenance phase the specific protocol resulted in an additional mean gain of +3Le (-2Le-8Le) at 11 months (mean final VA: 71Le (29Le-90Le)) or a mean gain of 17Le (1Le-33Le)). For 6/21 patients monthly injections were necessary throughout the study due to exudative persistence in OCT. The initial VA for this patient group was 52Le (28Le-70Le). A mean gain of 12Le (4Le-22Le) was obtained until the end of follow-up.
After the first three injections and the disappearance of exudation in OCT, the re-treatment with LUCENTIS° until VA stability brings no significant immediate gain. Over the year, however, the patients maintained their VA with a mean gain of +3Le confirming the monthly re-treatment studies (MARINA, ANCHOR). In most of the studies following a reactive PRN pattern (PrONTO, SUSTAIN, GEFAL) patients systematically lose letters as from the third month of monitoring. Present results will need to be confirmed on a greater scale, and over 24 months.
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