Fewer Ranibizumab Doses OK for mCNV

Intravitreal ranibizumab (Lucentis) significantly improved best-corrected visual acuity (BCVA) compared with verteporfin photodynamic therapy (vPDT) for patients with myopic choroidal neovascularization (mCNV) in the phase 3 RADIANCE trial, leading to FDA approval for the anti-VEGF agent in January 2017.

Further analyses of the phase 3 trial are examining treatment trends, since anti-VEGF therapy is a newly approved modality for mCNV. One observation was that patients required fewer overall treatments, as nearly half of patients in the trial only needed the initial 1 to 2 injections of ranibizumab to achieve optimal outcomes at 12 months. Findings from the assessment were presented at the 2017 American Society of Retina Specialists Annual Meeting.

"The RADIANCE trial provided definitive evidence that ranibizumab therapy was superior to the only FDA approved option, until recently, for myopic CNV," said lead investigator Paul Hahn, MD, PhD, an ophthalmologist in Teaneck, New Jersey. "Importantly, the study also showed that monthly dosing isn't important. Clinically significant gains can be obtained with less than monthly regimens."

The phase 3 trial randomized 276 patients with visual impairment due to mCNV to receive induction with ranibizumab as either 2 monthly injections (n = 105) or 1 injection (n = 116). Both induction arms were followed by retreatment based on visual acuity (VA) in the 2-injection arm or by disease activity (DA) in the 1 injection group. Fifty-five patients were randomized to vPDT. After 3 months, those in the vPDT arm could receive rescue ranibizumab, continue vPDT, or both at the investigator's discretion.

At month 3, BCVA improved by 12.1 letters from baseline in the 2-injection group and by 12.5 letters in the single-injection group, as compared with a 1.4 letter improvement with vPDT. Both ranibizumab doses were superior to vPDT (P <.00001). By month 12, the letter gains were 14.4 and 13.8 in the one- and two-injection arms, respectively.

Despite more than two-thirds of patients beginning treatment with ranibizumab at month 3, letter improvements at 12 months in the vPDT arm were not as substantial versus the induction ranibizumab groups. Overall, the 12-month letter improvement was 9.3 in the vPDT group. "As we've seen with other studies of VEGF therapy, the improvement doesn't quite catch up, which is probably related to the importance of early treatment," Hahn noted.

A greater proportion of patients in the ranibizumab arms had a ≥15 letter improvement, at 37.1% and 40.5% at month 3 and 48.6% and 51.7% at 12 months, in the 2-injection and 1-injection arms, respectively. In the vPDT arm, there was a ≥15 letter improvement for 14.5% of patients at 3 months and for 29.1% at 12 months.

In the 1-injection arm, patients received 3.5 mean injections of ranibizumab and in the 2-injection group 4.6 mean injections were administered. Altogether, 51% of patient received just 1 to 2 injections during the 12 months of the study. Thirty-four percent received 3 to 4 injections, and just 15% needed 6 to 12 injections.

"Unlike with macular degeneration, which is a chronic disease with chronic characteristics, patients with myopic CNV may have a difference disease course, and this limited amount of injections upfront may be all that is required to achieve deep remission," said Hahn. "However, 15% of patients did require 6 to 12 injections, demonstrating that there may be some patients with more chronic disease. This also indicates the necessity for a more personalized treatment."

There were no deaths or cases of endophthalmitis during the 12-month study period with ranibizumab. Overall, the ranibizumab safety profile was consistent with other approved indications, without any significant differences. The mCNV indication was the fifth gained by ranibizumab, since its initial approval in 2006.

Hahn P, Haskova Z, Quezada-Ruiz C, et al. Ranibizumab Improves Vision in Patients With Myopic Choroidal Neovascularization (mCNV): Results From the Phase III RADIANCE Trial. Presented at: 35th Annual Meeting of the American Society of Retina Specialists; August 11-15, 2017; Boston, Massachusetts.