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Fewer ranibizumab injections given in real-world scenarios than in clinical trials
Electronic medical records allow analysis of a large amount of data on real patients.
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Real-world results of ranibizumab therapy for eyes with neovascular age-related macular degeneration were achieved with fewer injections and hospital visits than in published randomized trials, a study found.
The Writing Committee for the U.K. Age-Related Macular Degeneration EMR Users Group reported that, in a study of 92,976 injections in 12,951 eyes of 11,135 patients, results differed from those of previous clinical trials.
“The key findings are that in large populations, in real life, we can get close to stable vision with fewer visits and fewer injections than in the clinical trials. In real life, we are getting reasonable visual results with lower treatment burden,” Adnan Tufail, MD, FRCOphth, the corresponding author, said in an interview with Ocular Surgery News. “For clinicians looking to see how good their outcomes are, the benchmark is not ANCHOR/MARINA but actually real-life outcomes in a large number of centers.”
The study also showed that visual acuity state is an important outcome, in addition to visual acuity gain, Tufail said.
“If you treat a patient with 20/20 vision, you’re not going to gain any vision but you’re going to keep them at 20/20, which is far better for a patient than starting at 20/200 and going up to 20/120. That gets lost in the clinical trial literature and in the way people describe things, which is driven to date by looking at visual acuity change from baseline,” he said.
Adnan Tufail
The study was published in Ophthalmology.
Study design and results
Investigators used electronic medical records to collect up to 5 years of data from 14 treatment centers in the United Kingdom. The centers used Lucentis (ranibizumab, Genentech) to treat neovascular AMD using a loading phase of three monthly injections and an as-needed re-treatment regimen.
Researchers recorded patient age, ETDRS visual acuity and injection episodes.
Primary outcome measures were baseline visual acuity, change in visual acuity, number of treatments and visits, and baseline characteristics affecting visual acuity change.
Mean age at first treatment was 79.1 years.
The percentage of patients who avoided moderate vision loss was 90% at 1 year, 84% at 2 years and 82% at 3 years.
Mean visual acuity for eyes followed for at least 3 years from a baseline of 55 letters was 57 letters at 1 year, 56 letters at 2 years and 53 letters at 3 years.
The proportion of eyes with visual acuity of 20/40 or better was 16% at baseline, 30% at 1 year and 2 years, and 29% at 3 years.
At 1 year, 17.4% of patients gained 15 letters of vision; at 2 years, that proportion was 18%. About 10% more patients in the ANCHOR, MARINA and CATT trials gained 15 letters at 1 year, the authors said.
The median number of treatments for eyes followed for at least 3 years was five at 1 year and four in year 2 and year 3. The ANCHOR and MARINA trials involved 12 injections over 1 year and 24 injections over 2 years.
The median number of outpatient visits was 9.2. at 1 year and 8.2 at 2 years and 3 years. There was an inverse relationship between baseline visual acuity and mean vision gain at 3 months, “which is not just a ceiling effect in patients with very good vision,” Tufail said. Older age was associated with lower presenting visual acuity.
Author observations
Data from phase 4 pivotal trials are somewhat limited in reflecting real-life practice because they are based on a limited population with selection bias, Tufail said. EMR data enable researchers to study real results in actual patients.
“What we can effectively do is potentially collect the outcomes of every patient who has an EMR record,” Tufail said. “That’s huge — a complete game-changer in the way you look at how drugs work in real life. You don’t capture a small proportion. You basically capture everyone.”
At the Association for Research in Vision and Ophthalmology annual meeting, Tufail’s colleagues analyzed this large data set further to explore what happens when an eye on an as-needed regimen is stable on optical coherence tomography and does not require an injection for a given period of time, which may help inform the risk trade-off in eyes on a treat-and-extend protocol.
“We generated Kaplan-Meier curves for every possible outcome if a patient has not required an injection for 3, 4, 5, 6, 12 months — what’s the time to requiring the next injection?” he said. “This actually informs the clinician for the first time what the potential risk is in terms of a risk-benefit trade-off between a patient having to come back all of the time and have lots of injections vs. the chance of them reactivating at time point X. We can now make more informed decisions with our patients about that trade-off.”
Tufail and colleagues completed a subsequent study comparing outcomes of first and second eyes treated with ranibizumab. The study will be published in Ophthalmology. – by Matt Hasson