Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study

Abstract

Aims To evaluate the efficacy and safety of intravitreal ranibizumab in patients with choroidal neovascularisation secondary to pathological myopia (myopic CNV). Data are from a pre-planned, 6-month interim analysis. Methods Phase II, open-label, single arm, multicentre, 12-month study, recruiting patients (aged Z18 years) with active primary or recurrent subfoveal or juxtafoveal myopic CNV, with a best-corrected visual acuity (BCVA) score of 24-78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye and a diagnosis of high myopia of at least À 6 dioptres. Patients received 0.5 mg ranibizumab administered intravitreally to the study eye, followed by monthly injections given as needed (based on a predefined algorithm) for up to 11 months. Results At 6 months, mean BCVA improved from baseline by 12.2 letters, as did central macular thickness (in this interim analysis defined as a measure of either central subfield macular thickness or centre point macular thickness) from baseline by 108 mm in the 48 study eyes of 48 patients. Fewer patients had centre-involving intraretinal oedema (13.0% vs 91.5%), intraretinal cysts (10.9% vs 57.4%), or subretinal fluid (13.0% vs 66.0%) at 6 months than at baseline. Patients received a mean of 1.9 retreatments, were satisfied with ranibizumab treatment, and well being was maintained. No new safety signals were identified. Conclusions Results from the planned interim analysis support the role of ranibizumab in the treatment of myopic CNV, with excellent efficacy achieved with a low number of injections and few serious adverse events.

Intravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization

“…20 In the current study, mean age, female-to-male ratio, refractive error, and axial length were typical for patients with myopic CNV, and thus these findings seem to be representative of the general population of patients with myopic CNV. 2,18,19 Patients in the MYRROR study had exclusively Asian ethnicity because the trial was only conducted in East-Asian countries; however, myopic CNV is also prevalent in other geographic regions outside of Asia. Because existing epidemiologic and clinical data show only differences in prevalence figures between different geographic regions but no other clinically relevant differences in natural history 2 or different outcomes with other anti-VEGF therapies, such as ranibizumab treatment, 19 it may be inferred that the results of the MYRROR study are also relevant to patients with myopic CNV outside of Asia.…”

Fluorescein Angiography and Spectral-Domain Optical Coherence Tomography for Monitoring Anti-VEGF Therapy in Myopic Choroidal Neovascularization

“…Two recent randomized clinical trials, the RADIANCE study and REPAIR study, provided evidence that a BCVA improvement may be obtained combining information from visual acuity response after intravitreal ranibizumab administration and assessment of CNV activity by means of OCT and/or FA [22,23,24]. In the RADIANCE study, ranibizumab was administered according to the presence/absence of CNV activity in one group and based on the visual acuity changes in the second group.…”

Neun-Jahres-Ergebnisse zur Ranibizumab-Monotherapie der choroidalen Neovaskularisation infolge pathologischer Myopie

“…Auf Grundlage der Studien REPAIR [18,19] und RADIANCE [20], die die Rolle von Ranibizumab als neue Standardtherapie in der Behandlung von mCNV bestätigten, erfolgte 2013 die Zulassung in der Europäischen Union für die Behandlung der PM-bedingten CNV [21]. …”