Abstract
Purpose :
Patients of Asian descent are at a higher risk of developing myopic choroidal neovascularization (mCNV), a vision-threatening complication of pathological myopia. This post-RADIANCE retrospective cohort study assessed the long-term efficacy, safety, and treatment burden of intravitreal 0.5 mg ranibizumab (RBZ) in East Asian patients with mCNV over the 36 months following the 12-month, phase 3 RADIANCE trial (NCT01217944).
Methods :
The RADIANCE trial compared verteporfin photodynamic therapy vs 2 treatment regimens of 0.5 mg RBZ in patients with mCNV: guided by either disease activity or visual stability criteria. The post-RADIANCE retrospective analysis examined the safety and efficacy of RBZ in patients of East Asian descent who completed RADIANCE and attended at least 1 follow-up visit in the 36 months (M13–48) following the trial. The primary outcome measure was mean BCVA change from baseline to each visit over the 36-month follow-up study. Secondary outcome measures included recurrence of mCNV in the study eye and ocular adverse events (AEs) during the 36-month follow-up.
Results :
In this retrospective analysis of post-RANDIANCE patients (N=41; 14.8% of RADIANCE), mean BCVA gains from RADIANCE baseline were 14.3 ± 11.4 ETDRS letters (n=40; P < 0.0001) at M12, and were maintained through the follow-up period to 16.3 ± 18.7 (n=16, P = 0.0034) at M48. From M13–48, only 7 patients (17.1%) required additional anti-VEGF injections (5.0 ± 5.9; group A), while 34 (82.9%) did not (group B). The mean central retinal thickness (CRT; µm) in groups A and B in the post-RADIANCE study period was comparable (379.0 ± 72.8 and 382.1 ± 108.6). Of the 41 patients in the follow-up study, 4 patients had recurrences (2 reactivations of previously regressed mCNV and 2 newly formed). Of these, 2 (4.9%) experienced a single episode, 2 (4.9%) had a second recurrence. No patients experienced a third recurrence during the follow-up study. Ocular AEs were reported in 5 (12.2%) patients, however, none were considered serious or related to RBZ treatment.
Conclusions :
The significant vision gains achieved in East Asian mCNV patients with RBZ treatment at M12 were maintained over an additional 36-month period with only a minority of patients requiring additional injections. Few patients experienced recurrence of mCNV. No new safety findings were reported.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.