Session Title: Vascular Diseases and Diabetic Retinopathy I
Session Date/Time: Thursday 11/09/2014 | 08:00-10:00
Paper Time: 08:56
Venue: Boulevard C
First Author: : J-FKorobelnik FRANCE
Co Author(s): : L. Kodjikian C. Delcourt V. Gualino R. Leaback M.E. Velard
In November 2010, the French National Authority for Health (Haute Autorité de Santé) requested implementation of a study to monitor outcomes of patients receiving Ozurdex® (dexamethasone intravitreal implant 0.7 mg). The study (LOUVRE) protocol was validated by an independent scientific committee and by the French National Authority for Health in 2011. LOUVRE was designed to characterize the prescribing patterns, efficacy, and safety of dexamethasone intravitreal implant when used in the French clinical setting for the treatment of macular edema due to retinal vein occlusion. This abstract presents interim efficacy and safety results obtained during the first 6 months of follow-up.
Clinical practices at 48 metropolitan sites (75% private, 25% public) throughout France that used dexamethasone intravitreal implant. Physicians were selected at random.
This 24-month longitudinal, observational, multicentre, epidemiologic study included patients presenting consecutively with macular edema due to retinal vein occlusion. Eligible patients were treatment naïve or could have received previous treatment of any type. Treatment with dexamethasone intravitreal (IVT) implant was at the physician’s discretion, based on responses to a screening questionnaire completed by the patient. Reasons for non-inclusion were collected. Assessments were conducted at baseline and grouped around week 6, and months 4, 6, 12, 18 and 24 of the study, and included a follow-up questionnaire completed by the physician. The primary endpoint was the change in best corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Scale [ETDRS]) from baseline to month 6. Secondary endpoints included change in BCVA from baseline, proportion of patients with increase of ≥15 letters of vision from baseline, and adverse event reports at each follow-up assessment.
Of 520 patients presenting to 44 participating physicians, 364 met all eligibility criteria including 142 treatment-naïve and 77 previously treated, dexamethasone-naïve patients. Mean age was 71 years; the majority were men (53.9%). Branch retinal vein occlusion (BRVO) was diagnosed in 54.7% and central retinal vein occlusion (CRVO) in 45.3% of patients. The mean time since macular oedema onset was 12.3 months. Mean BCVA increased from 47.43 letters at baseline to 54.18 letters at month 6 (mean gain of +5.97 letters [95% confidence interval, 3.75 – 8.19] at month 6, p<0.0001) and 33% of patients presented with an increase of at least 15 letters. Improvement in BCVA was greater (p=0.01) in patients (174 patients) with recent-onset macular oedema than in patients diagnosed ≥3 months previously. Mean BCVA in patients with recent-onset macular oedema increased from 43.12 letters at baseline to 54.85 letters at month 6, (mean gain of +11.72 letters, p<0.0001) and 41.5% of those patients presented with a 15-letter increase. Both the BRVO and CRVO subgroups showed significant increases in BCVA from baseline (p=0.0001). Ninety-six (96/364) patients reported adverse events related to treatment (26.4%). The most common treatment-related adverse events were ocular hypertension (88/364; 24.2%) and cataract (28/364; 7.7%).
This observational, multicentre, epidemiological study in patients with macular oedema after retinal vein occlusion demonstrated that patients treated in the clinical setting have efficacy and safety outcomes similar to that seen in the phase 3 clinical trial. BCVA increased significantly during follow-up and seemed to be strongly correlated with the time since onset of macular oedema and whether the patient had already received treatment. The effects of treatment were most marked in all treatment-naive patients who were naturally those whose condition had been diagnosed most recently (and who were also starting with the poorest visual acuity). As expected, the most commonly encountered adverse events are ocular hypertension and cataract.