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Phase IIb clinical trial of ranibizumab for the treatment of uveitic and idiopathic choroidal neovascular membranes
  1. Ester Carreño1,
  2. Tanya Moutray1,
  3. Konstantinos Fotis1,
  4. Richard W J Lee1,2,3,
  5. Andrew D Dick1,2,3,
  6. Adam H Ross1,
  7. Clare Bailey1
  1. 1Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
  2. 2Faculty of Medicine and Dentistry, School of Clinical Sciences, University of Bristol, Bristol, UK
  3. 3National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
  1. Correspondence to Dr Ester Carreño, Bristol Eye Hospital, Lower Maudlin Street, Bristol BS1 2LX, UK; Ester.Carreno-Salas{at}UHBristol.nhs.uk

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.

  • Retina
  • Inflammation
  • Clinical Trial
  • Treatment Medical
  • Neovascularisation

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