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 ≥18 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 -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 μm 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.

• Authors: A Tufail, P J Patel, S Sivaprasad, W Amoaku, A C Browning, M Cole, R Gale, S George, A J Lotery, M Majid, M McKibbin, G Menon, Y Yang, C Andrews, C Brittain, A Osborne
• Journal: Eye (London, England) (Eye (Lond)) Vol. 27 Issue 6 Pg. 709-15 (Jun 2013) ISSN: 1476-5454 [Electronic] England
• PMID: 23449508 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal, Humanized
• Ranibizumab

Topics

• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Choroidal Neovascularization (drug therapy, etiology)
• Female
• Humans
• Intravitreal Injections
• Male
• Middle Aged
• Myopia (complications)
• Patient Satisfaction
• Ranibizumab
• United Kingdom
• Visual Acuity