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Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8.

RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia.

Author information

  • 1Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland. Electronic address: sebastian.wolf@insel.ch.
  • 2Eye Clinic, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • 3Department of Ophthalmology, P. Stradins University Hospital, Riga Stradins University, Riga, Latvia.
  • 4Department of Translational Surgery and Medicine - Eye Clinic, University of Florence, Florence, Italy.
  • 5Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan.
  • 6Shri Bhagwan Mahavir Vitreoretinal Services, Vision Research Foundation, Sankara Nethralaya, Chennai, India.
  • 7Singapore Eye Research Institute, Singapore National Eye Centre, National University of Singapore, Singapore.
  • 8Faculty of Medicine, University of Coimbra, Coimbra, Portugal; Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
  • 9Novartis Pharma AG, Basel, Switzerland.

Abstract

OBJECTIVE:

To compare the efficacy and safety of ranibizumab 0.5 mg, guided by visual acuity (VA) stabilization or disease activity criteria, versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (CNV).

DESIGN:

Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study.

PARTICIPANTS:

Patients (N = 277) with visual impairment due to myopic CNV.

METHODS:

Patients were randomized to receive ranibizumab on day 1, month 1, and thereafter as needed guided by VA stabilization criteria (group I, n = 106); ranibizumab on day 1 and thereafter as needed guided by disease activity criteria (group II, n=116); or vPDT on day 1 and disease activity treated with ranibizumab or vPDT at investigators' discretion from month 3 (group III, n = 55).

MAIN OUTCOME MEASURES:

Mean average best-corrected visual acuity (BCVA) change from baseline to month 1 through months 3 (primary) and 6, mean BCVA change and safety over 12 months.

RESULTS:

Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 (group I: +10.5, group II: +10.6 vs. group III: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both P<0.0001). Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month 1 through month 6 (group II: +11.7 vs. group I: +11.9 ETDRS letters; P<0.00001). Mean BCVA change from baseline to month 12 was +13.8 (group I), +14.4 (group II), and +9.3 ETDRS letters (group III). At month 12, 63.8% to 65.7% of patients showed resolution of myopic CNV leakage. Patients received a median of 4.0 (group I) and 2.0 (groups II and III) ranibizumab injections over 12 months. No deaths or cases of endophthalmitis and myocardial infarction occurred.

CONCLUSIONS:

Ranibizumab treatment, irrespective of retreatment criteria, provided superior BCVA gains versus vPDT up to month 3. Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month 6. Over 12 months, individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well tolerated in patients with myopic CNV.

Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

PMID:
24326106
[PubMed - indexed for MEDLINE]
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