Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France

Abstract

PurposeTo evaluate patterns of use and long-term efficacy and safety of dexamethasone intravitreal implant (DEX implant) in the treatment of macular edema secondary to branch or central retinal vein occlusion (BRVO, CRVO) in French clinical practice.MethodsA 24-month, prospective, multicenter, longitudinal, observational study (LOUVRE) conducted at 48 randomly selected sites in metropolitan France enrolled consecutive adult patients with macular edema following retinal vein occlusion (RVO) who were treated with DEX implant at baseline. Re-treatment with DEX implant and use of other RVO treatments was at the physician’s discretion. The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline to month 6. Secondary endpoints included change in BCVA, intraocular pressure (IOP), adverse events, and RVO treatments administered through month 24.ResultsThe analysis population of 375 patients (53.9 % BRVO, 46.1 % CRVO) received a mean of 2.6 DEX implant injections over 2 years; mean time between injections was 6.6 months. Mean (SD) change in BCVA from baseline was 5.1 (19.0) letters at month 6 (p < 0.001) and 4.6 (22.3) letters at month 24 (p < 0.001). During the study, 208 patients (55.5 %) received treatment other than DEX implant for RVO, usually laser or ranibizumab therapy, with first use of other therapy occurring at a mean of 8.7 months. Mean change from baseline BCVA at month 6 was 5.5 letters (p < 0.001, N = 254) in patients who had received only DEX implant and 4.2 letters (p = 0.006, N = 121) in patients who had received additional other RVO treatment during the first 6 months. At month 24, mean change from baseline BCVA was +20.7 letters in patients treated with a single DEX implant only (p < 0.001), +4.9 letters in patients treated with ≥2 DEX implants only (p = 0.029), and +2.3 letters in patients treated with DEX implant and other RVO treatment (p = 0.143). The most common adverse events (incidence) were cataract progression (39.7 %) and increased IOP (34.4 %). No glaucoma incisional surgeries were required.ConclusionsEfficacy and safety of DEX implant in the treatment of RVO-associated macular edema were demonstrated in the French clinical setting. Patients who switched from DEX implant to other RVO treatments did not have improved outcomes.The study is registered at ClinicalTrials.gov with the identifier NCT01618266.

Long-term visual outcome and its predictors in macular oedema secondary to retinal vein occlusion treated with dexamethasone implant

“…Our study might have selected patients with comparatively worse treatment response with need for retreatment and therefore longer follow-up. This might also explain the lower rate of patients with a BCVA gain ≥15 letters after 24 months in our study (21.3%) compared with LOUVRE study (38.7%), while the rate of patients with BCVA gain ≥15 letters after 6 months was similar in both studies (32.9% vs 31.3% in LOUVRE) 10. Furthermore, data on anatomical outcomes in our study demonstrated that a proportion of the patients might have been undertreated, reflecting the scenario in the real-world setting.…”

“…The LOUVRE study reported a significant improvement of 4.8 letters in RVO eyes treated with DEX implant after 24 months 10. The better outcome reported in this trial compared with our results might be explained by its prospective design and a discontinuation rate of 26%, among others due to lack of treatment efficacy 10.…”

“…Thirty-one per cent gained ≥15 letters after 6 months and 38.7% after 24 months 10. Despite the favourable reported overall outcome, certain patient subgroups did not improve sufficiently after DEX implant.…”

Twelve-month Outcomes of Dexamethasone Implant Treatment in Macular Edema Secondary to Retinal Vein Occlusion in Real Life

“…As needed IDI regimens have been followed in treatment of various diseases, and efficacy of single injection has been found to be about 3 to 4 months (12-17). Korobelnik et al evaluated real-life outcomes of IDI in RVO patients in a multicenter prospective study conducted in France (12). Length of study follow-up was 24 months, and 279 patients were included.…”

Restoration of photoreceptor layer and its prognostic value in eyes with macular edema due to branch retinal vein occlusion

“…The most common cause of visual loss in BRVO is ME [4][5][6][7]. There are some treatment options for macular edema such as intravitreal dexamethasone implants, laser treatment, and intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents [8,9]. These treatments have effects on resolution of ME.…”