Laird Harrison

September 17, 2015

NICE, France — Visual acuity remains stable or continues to improve over 5 years in most patients treated with ranibizumab (Lucentis, Genentech) for neovascular age-related macular degeneration under "real-life" conditions, a new study shows.

The results are encouraging. "The great majority of patients avoided vision loss and one-fifth of patients improved," said Cristina Fonseca, MD, from the Centro Hospitalar e Universitario de Coimbra in Portugal.

She presented the findings here at the 15th EURETINA Congress.

Although 1-year follow-up data from the LUMINOUS postmarketing trial showed promise in real-life conditions, as previously reported by Medscape Medical News, results with antivascular endothelial growth-factor (VEGF) treatments have been less impressive in the clinic than in clinical trials.

In fact, in some retrospective studies, clinical practice results have been disappointing.

Dr Fonseca and her colleagues retrospectively analyzed outcomes in 53 eyes from 50 patients with neovascular age-related macular degeneration. All patients completed 60 months of follow-up.

The patients had a clinic visit every 4 to 6 weeks after being treated with intravitreal ranibizumab injections. They were retreated if new or persistent subretinal fluid was seen on optical coherence tomography, there was an increase in central macular thickness, there was a deterioration in best-corrected visual acuity, or there were signs of choroidal neovascularization on funduscopy or angiography.

During each visit, patients underwent extended ophthalmologic examinations that included measurement of best-corrected visual acuity, funduscopy, spectral-domain optical coherence tomography, fluorescein angiography, and when necessary, indocyanine green angiography.

At baseline, mean visual acuity was 46.2 ETDRS and mean central macular thickness was 329.6 µm. Best-corrected visual acuity improved in the first 3 years, but had decreased to 43.0 ETDRS at 5 years. Central macular thickness improved throughout the 5 years.

Table: Changes in Anatomy and Visual Acuity Over Time

Year ETDRS Letters Central Macular Thickness, µm
1 4.0 –2.5
2 2.6 –5.4
3 1.3 –6.3
4 –2.8 –6.4
5 –3.2 –4.4

 

After 60 months, visual acuity decreased in 28% of eyes, remained stable in 51%, and increased in 21%.

The results were not as good as those in the HORIZON trial, where mean change in best-corrected visual acuity was –0.1 ETDRS letters after 5 years (Ophthalmology. 2012;119:1175-1178).

However, Dr Fonseca and her colleagues report that their eyes fared better than untreated and crossover eyes in HORIZON, where the loss was 16.1 letters. And the mean number of injections per year was lower in their eyes than in HORIZON eyes (2.2 vs 4.0).

 
It's pretty well known that the results are not as good as in the clinical trials.
 

After 5 years, 16 eyes (30.2%) were still receiving injections. The main cause for interruption of treatment was disease inactivity, which occurred in 64.2% of the interrupted cases.

The main predictors of final best-corrected visual acuity were treatment duration and initial visual acuity, but the total number of treatments was not an independent predictor of final score.

"It's pretty well known that the results are not as good as in the clinical trials," said session moderator Guy Donati, MD, from Clinique la Colline in Geneva.

This study suggests the difficulty in maintaining therapy over a long period of time. "When you look at 5-year follow-up, there are usually some patients who have not completed the follow-up as recommended," he told Medscape Medical News.

Many patients with neovascular age-related macular degeneration suffer from other illnesses or frailty, Dr Donati explained, pointing out that the average age in this study was 76 years.

"Maybe you broke a leg and you're in the hospital, so you miss treatments and your visual acuity declines," he said.

The retrospective nature of the study is a weakness because it is biased toward patients who were available for follow-up after 5 years, Dr Fonseca acknowledged.

Dr Fonseca and Dr Donati have disclosed no relevant financial relationships.

European Society of Retina Specialists 15th EURETINA Congress. Presented September 17, 2015.

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