title: Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes.
abstract: OBJECTIVE
  To assess the efficacy of intravitreal ranibizumab for the treatment of new onset inflammatory choroidal neovascularisation (iCNV), including both uveitic and idiopathic CNVs.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  2008-007476-19, results.
authors.affiliation: Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Ester
authors.initials: E
authors.lastname: Carreño
authors.affiliation: Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Tanya
authors.initials: T
authors.lastname: Moutray
authors.affiliation: Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Fotis
authors.affiliation: Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK Faculty of Medicine and Dentistry, School of Clinical Sciences, University of Bristol, Bristol, UK National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Richard W J
authors.initials: RW
authors.lastname: Lee
authors.affiliation: Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK Faculty of Medicine and Dentistry, School of Clinical Sciences, University of Bristol, Bristol, UK National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Dick
authors.affiliation: Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Adam H
authors.initials: AH
authors.lastname: Ross
authors.affiliation: Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Bailey
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005451:Fluorescein Angiography; D005654:Fundus Oculi; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage*; D012160:Retina / Q000000981:diagnostic imaging*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014605:Uveitis / Q000175:diagnosis / Q000188:drug therapy*; D014792:Visual Acuity; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab
keywords: Clinical Trial; Inflammation; Neovascularisation; Retina; Treatment Medical