title: RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia.
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).
  
  
  METHODS
  Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
authors: Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland. Electronic address: sebastian.wolf@insel.ch.
authors: Sebastian
authors: S
authors: Wolf
authors: Eye Clinic, Lithuanian University of Health Sciences, Kaunas, Lithuania.
authors: Vilma Jurate
authors: VJ
authors: Balciuniene
authors: Department of Ophthalmology, P. Stradins University Hospital, Riga Stradins University, Riga, Latvia.
authors: Guna
authors: G
authors: Laganovska
authors: Department of Translational Surgery and Medicine - Eye Clinic, University of Florence, Florence, Italy.
authors: Ugo
authors: U
authors: Menchini
authors: Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan.
authors: Kyoko
authors: K
authors: Ohno-Matsui
authors: Shri Bhagwan Mahavir Vitreoretinal Services, Vision Research Foundation, Sankara Nethralaya, Chennai, India.
authors: Tarun
authors: T
authors: Sharma
authors: Singapore Eye Research Institute, Singapore National Eye Centre, National University of Singapore, Singapore.
authors: Tien Y
authors: TY
authors: Wong
authors: Faculty 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.
authors: Rufino
authors: R
authors: Silva
authors: Novartis Pharma AG, Basel, Switzerland.
authors: Stefan
authors: S
authors: Pilz
authors: Novartis Pharma AG, Basel, Switzerland.
authors: Margarita
authors: M
authors: Gekkieva
mesh_terms: D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D047728:Myopia, Degenerative / Q000150:complications* / Q000175:diagnosis; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use; D011166:Porphyrins / Q000627:therapeutic use; D000069579:Ranibizumab; D019233:Retreatment; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D000077362:Verteporfin; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D017319:Photosensitizing Agents; D011166:Porphyrins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000077362:Verteporfin; D000069579:Ranibizumab