Ranibizumab Holds Visual Line in Real-World Study

Neil Osterweil

April 16, 2014

TOKYO — Ranibizumab (Lucentis, Genentech) maintains or slows the decline in visual acuity in a large proportion of patients with neovascular age-related macular degeneration, according to 1-year follow-up data from a "real-world" clinical study.

These patients "achieved good visual acuity outcomes at 12 months, irrespective of pretreatment status, with relatively low numbers of monitoring visits and injections," said Paul Mitchell, MD, professor of clinical ophthalmology and eye health at the University of Sydney in Australia.

The LUMINOUS postmarketing trial is a worldwide 5-year observational study of all approved ranibizumab indications. It is designed to evaluate the safety and effectiveness of the vascular endothelial growth-factor (VEGF) inhibitor in clinical practice.

Dr. Mitchell presented 1-year follow-up results from the first 2000 patients with neovascular age-related macular degeneration enrolled in the LUMINOUS trial here at the World Ophthalmology Congress 2014.

Investigators plan to enroll 30,000 patients from 600 treatment sites in more than 40 countries.

Ranibizumab is approved in the United States for the treatment of neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion, and elsewhere for the treatment of visual impairment related to choroidal neovascularization secondary to pathologic myopia.

Results of the first interim analysis were presented at the EURETINA Congress in 2012, as reported by Medscape Medical News.

In that analysis, 2112 of the 2163 patients had neovascular age-related macular degeneration, and more than 85% of those patients had previously been treated with ranibizumab. Only 275 of the 2163 patients were treatment-naïve; 8 had been treated previously with other unspecified therapies.

At baseline, mean visual acuity was better in previously treated than in treatment-naïve patients, and central retinal thickness on optical coherence tomography was lower.

One Year Follow-up Data

In the 1-year follow-up data reported by Dr. Mitchell, visual outcomes were good in previously treated and treatment-naïve patients.

Change in ETDRS letter score from baseline was worse in previously treated than in treatment-naïve patients (–1.1 vs +4.1 letters).

The 65 patients who have been on ranibizumab for more than 5 years (they were already on the drug at study entry) have maintained good visual acuity throughout that period, said Dr. Mitchell.

The rate of ocular serious adverse events was low. In previously treated patients, there were 2 retinal detachments, 1 ectropion, 1 retinal pigment epithelium tear, 1 case of uveitis, 1 reported visual impairment, 1 case of endophthalmitis, and 1 retinal hemorrhage. In treatment-naïve patients, there was 1 case of endophthalmitis and 2 retinal hemorrhages.

The data on long-term outcomes in some patients could be subject to ascertainment bias, said Adnan Tufail, MD, consultant ophthalmologist at Moorfields Eye Hospital in London, United Kingdom. Presumably, patients who did not respond to ranibizumab would not have stayed on the drug and, therefore, would not be included in later analyses, he explained.

Dr. Mitchell acknowledged that such bias is "a very important issue," and that to overcome the problem it might be necessary to conduct a last observation carried forward analysis.

The LUMINOUS trial is supported by Novartis. Dr. Mitchell reports financial relationships with Novartis, Bayer, Abbott, and Allergan. Dr. Tufail reports financial relationships with Novartis.

World Ophthalmology Congress (WOC) 2014: Abstract FP-FR-20-8. Presented April 4, 2014.


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