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

Br J Ophthalmol. 2016 Sep;100(9):1221-6. doi: 10.1136/bjophthalmol-2015-307806. Epub 2015 Dec 16.

Abstract

Aim: 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).

Conclusion: 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.

Trial registration number: 2008-007476-19, results.

Keywords: Clinical Trial; Inflammation; Neovascularisation; Retina; Treatment Medical.

Publication types

  • Clinical Trial

MeSH terms

  • 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

Substances

  • Angiogenesis Inhibitors
  • Ranibizumab