OZURDEX TRIALS

Patients with macular oedema due to retinal vein occlusion who received the slow-release intravitreal dexamethasone implant Ozurdex (Allergan) showed significant improvements in best corrected visual acuity (BCVA), reported French researchers at the 14th EURETINA Congress in London.

“This observational, multicentre French study in patients with macular oedema after retinal vein occlusion replicates what we have seen before in the clinical trials of Ozurdex in terms of efficacy and safety. 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,” said Jean-Francois Korobelnik MD, FEBO.

Dr Korobelnik, of University Hospital Bordeaux, France, noted that the effects of treatment were most marked in treatment-naïve patients. As with the phase III trials, the most commonly encountered adverse events were ocular hypertension and cataract.

Dexamethasone is the first agent to be approved and validated for the treatment of macular oedema related to retinal vein occlusion, said Dr Korobelnik.

In November 2010 the French National Authority for Health (Haute Autorité de Santé) requested a study to monitor the outcomes of patients treated with that implant. As a result, the LOUVRE protocol was validated by an independent scientific committee and was conducted after the authorities approved it in 2011.

The aim of the study was to assess the prescribing patterns, efficacy and safety of dexamethasone intravitreal implant when used in the French clinical setting for the treatment of macular oedema due to retinal vein occlusion.

Dr Korobelnik presented the six-month interim data from the 24-month study carried out at 48 centres in France, 75 per cent of them private and 25 per cent public. Eligible patients were treatment-naïve or could have received previous treatment of any type. Treatment with dexamethasone intravitreal implant was at the physician’s discretion, based on responses to a screening questionnaire completed by the patient. Of 520 patients that initially enrolled for the study, 383 patients were treated, and 276 were evaluated at six months.

Primary endpoint

Assessments were conducted at baseline and grouped around week six, and months four, six, 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 from baseline to month six.

Secondary endpoints included change in BCVA from baseline and the proportion of patients with an increase of more
than 15 letters of vision from baseline, as well as adverse event reports at each
follow-up assessment.

Branch retinal vein occlusion (BRVO) was diagnosed in 55 per cent and central retinal vein occlusion (CRVO) in 45 per cent of patients. The mean patient age was 70 years, and around 45 per cent of patients were treatment-naïve. The mean time for macular oedema onset was 11 months and the mean BCVA was 47 letters at baseline.

At six months, 47 per cent of patients received one injection, 51 per cent received two injections, and six patients received three injections, according to Dr Korobelnik.

Turning to the results, Dr Korobelnik said that the mean change in BCVA from baseline at six months differed according to the time of onset of macular oedema.

“The improvement in BCVA was greater in patients with recent-onset macular oedema than in those diagnosed more than three months previously. The gain was almost 12 letters for those with recent-onset oedema compared to just two letters for those with oedema over three months.”

The most common treatment-related adverse events were ocular hypertension in 26 per cent of patients and some degree of cataract in nine per cent of the eyes.

Jean-Francois Korobelnik:

jean-francois.korobelnik@chu-bordeaux.fr