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‘Real-life’ study provides data for anti-VEGF treatment in diverse RVO population
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LONDON — The LUMINOUS study, the largest prospective, observational study in medical retina, continues to provide a valuable source of real-world Lucentis data, according to a speaker here.
Ben J. Burton
“There is a wealth of ranibizumab (Lucentis, Genentech) evidence available from randomized clinical trials, but real-life studies deal with a more diverse population, providing long-term follow-up data and safety monitoring from a large and varied population that facilitates detection of rare safety events,” Ben J. Burton, MRCP, FRCOphth, said at the Euretina Congress.
The LUMINOUS study began in 2011 and involves 600 sites in more than 40 countries, with a target enrollment of 30,000 patients. Thus far, 26,000 patients have been recruited, the vast majority of whom have age-related macular degeneration; approximately 4.5% have diabetic macular edema, and 2.4% have retinal vein occlusion (RVO), according to Burton.
Burton reported on the baseline characteristics of patients with RVO, which include a much wider age range than in clinical trials, with a mean of 69 years.
“Patients with comorbidities at baseline, such as stroke, family history of coronary artery disease and diabetes, were also included — a population that would not be seen in clinical trials,” he said.
Baseline visual acuity range was also greater, since more patients with lower vision were treated.
The percentage of patients with branch retinal vein occlusion and visual acuity worse than 34 letters was about 25%, compared with 9.9% in the BRAVO study. The percentage of patients with central retinal vein occlusion was 30% compared with 23% in the CRUISE study, according to Burton.
“It is also reassuring to know that patients previously treated with ranibizumab had better vision and a thinner retina on optical coherence tomography than treatment-naïve patients,” he said.
Disclosure: Burton receives advisory board fees and speaker fees from Novartis.