Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes

• Published in: British journal of ophthalmology Vol. 100; no. 9; p. 1221
• Main Authors: Carreño, Ester, Moutray, Tanya, Fotis, Konstantinos, Lee, Richard W J, Dick, Andrew D, Ross, Adam H, Bailey, Clare
• Format: Journal Article
• Language: English
• Published: England 01-09-2016
• Subjects: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors - administration & dosage; Choroidal Neovascularization - diagnosis; Choroidal Neovascularization - drug therapy; Dose-Response Relationship, Drug; Female; Fluorescein Angiography; Fundus Oculi; Humans; Intravitreal Injections; Male; Middle Aged; Ranibizumab - administration & dosage; Retina - diagnostic imaging; Tomography, Optical Coherence; Treatment Outcome; Uveitis - diagnosis; Uveitis - drug therapy; Visual Acuity; Young Adult; Neovascularisation; Retina; Treatment Medical; Inflammation; Clinical Trial
• ISSN: 1468-2079
• DOI: 10.1136/bjophthalmol-2015-307806

To assess the efficacy of intravitreal ranibizumab for the treatment of new onset inflammatory choroidal neovascularisation (iCNV), including both uveitic and idiopathic CNVs.
Single-centre, open-label, non-randomised Phase IIb clinical trial. Patients fulfilling strict entry criteria of new onset iCNV were given monthly intravitreal ranibizumab injections for 3 months. Thereafter, re-treatment was based on evidence of persisting activity. All patients completed trial follow-up. Optical coherence tomography (OCT) and best-corrected visual acuity (BCVA) were performed at every visit. Fluorescein angiography was performed at baseline, months 4 and 12. Descriptive analysis and Wilcoxon non-parametric test were performed for analysis.
15 patients, 10 women with a mean age of 48.8 years (range 24-85 years) were included in the study. The mean number of injections was 4.33 (range 3-7). There was a statistically significant difference in the BCVA at month 4 (p=0.001) and at month 12 (p=0.001) compared with baseline. The mean gain in BCVA at month 4 compared with baseline was 20±15.36 letters (mean±SD), and at month 12 was 21±16.97 letters. There was a statistically significant difference in the mean central subfield thickness (CST) at baseline versus month 4 (p=0.003) and month 12 (p=0.001).
Patients gained vision (mean of 21 letters at 12 months) and showed reduced CST. These results support the continued use of ranibizumab in the treatment of iCNV.
2008-007476-19, results.