Patients treated with ranibizumab (Lucentis, Genentech) for diabetic macular oedema (DMO) in the National Health Service of the United Kingdom can fare about as well as patients in clinical trials, a review of patient records suggests.
“This Moorfields study on a cohort of 200 eyes shows that results from landmark clinical trials are reproducible in clinical practice to a large extent,” wrote Namritha Patrao and colleagues at Moorfields Eye Hospital and University College of London, United Kingdom.
They published the finding in American Journal of Ophthalmology.
In large randomized clinical trials, anti-vascular endothelial growth factor (VEGF) treatments including ranibizumab have achieved much more success than any previous therapy. In these trials, about half of patients gained 2 lines of best-corrected visual ETDRS visual acuity, and almost a third gained 3 lines.
The European Medicines Agency licensed ranibizumab in 2011 based on some of these trials.
However, clinical practice presents challenges not always present in trials. A multiethnic population with varying levels of diabetic control, multiple comorbidities, and difficulty attending appointments complicates care.
Patrao and colleagues wanted to know whether patients treated in National Health Service clinics would enjoy the same benefits from treatment as patients in trials.
They looked at records on 200 eyes in 164 patients treated at the Moorfields Eye Hospital. Of these patients, 21.95% had bilateral injections. Their mean baseline visual acuity was 54.4 letters and mean central subfield thickness was 490.16 µm.
The eyes received 3 monthly injections of 0.5 mg ranibizumab, then further injections at the clinician’s discretion aimed at achieving stability based on twice monthly tests of visual acuity and optical coherence tomography (OCT). Laser therapy and panretinal photocoagulation were administered at the clinician’s discretion.
The researchers were able to follow 195 eyes for 12 months, of which 4 had missing visual acuity records.
The remainder gained a mean of 6.6 letters, with 40.3% gaining at least 10 letters, 8.9% losing at least 10 letters, and 6.3% losing at least 15 letters.
Among those treated in both eyes, the eye treated first had a mean visual acuity gain 7.42 letters and the eye treated second had a mean gain of 9.33 letters.
Those who started with 60 letters or fewer gained a mean of 8.8 letters, while those with a baseline between 61 and 73 letters lost a mean of 4.3 letters.