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Two‐year, Prospective, Multicenter Study of the Use of Dexamethasone Intravitreal Implant for Treatment of Macular Edema Secondary to Retinal Vein Occlusion in France
Author(s) -
Gualino V.,
Korobelnik J.F.,
Kodjikian L.,
Delcourt C.,
Leaback R.,
Pinchinat S.,
Velard M.E.
Publication year - 2015
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2015.0653
Subject(s) - medicine , macular edema , dexamethasone , clinical endpoint , adverse effect , retinal vein , occlusion , visual acuity , prospective cohort study , ophthalmology , observational study , surgery , randomized controlled trial
Purpose To characterize patterns of use, efficacy, and safety of dexamethasone intravitreal implant ( DEX ) in treatment of macular edema ( ME ) due to retinal vein occlusion ( RVO ) in the French clinical setting. Methods A 24‐month, observational, prospective, epidemiological study conducted at 48 randomly selected sites in France enrolled consecutive patients with ME due to RVO who were treated with DEX at baseline. DEX re‐treatment and use of other RVO treatments was at the physician's discretion. The primary endpoint was change in best‐corrected visual acuity ( BCVA ) from baseline to month 6. Secondary endpoints included BCVA change from baseline and adverse events through month 24. Results Patients (n = 375) received a mean of 2.6 DEX injections (range, 1–7) over 2 years; 167 received DEX only and 208 also received other types of RVO treatment. Mean ( SD ) change from baseline BCVA was +5.1 (19.0) ETDRS letters at month 6 ( P < 0.001) and +4.6 (22.3) letters at month 24 ( P < 0.001). For patients treated only with DEX during the study, mean ( SD ) change from baseline BCVA was +8.1 (20.9) letters ( P < 0.001) at 24 months, compared with +2.5 (23.0) letters ( P = 0.092) for patients moved to other treatments. BCVA improved significantly from baseline at 6 and 24 months in subgroups defined by diagnosis (branch RVO , central RVO ), previous treatment, duration of ME , and pattern of DEX use. The most common adverse events were ocular hypertension and cataract. Conclusions Patients with RVO ‐related ME treated with DEX in the French clinical setting had efficacy and safety outcomes similar to those seen in the phase 3 registration trials. BCVA gains were maintained over 2 years and largest in patients with recent onset (<3 months) ME , confirming the benefit of early treatment.