Skip to main content
. 2016 Dec 15;2016(12):CD011160. doi: 10.1002/14651858.CD011160.pub2

NCT01922102 (Brilliance).

Trial name or title Efficacy and Safety of Ranibizumab 0.5 vs Veteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia (Brilliance)
Methods Allocation: randomised
Endpoint classification: safety/efficacy study
Intervention model: parallel assignment
Masking: double masked (participant, investigator, outcomes assessor)
Primary purpose: treatment
Participants 475 participants
Countries: China, Hong Kong, India, Korea, Philippines and Thailand
Interventions Experimental: Group 1: ranibizumab 0.5 mg driven by visual acuity stability criteria
Experimental: Group 2: ranibizumab 0.5 mg driven by disease activity criteria
Active comparator: Group 3: verteporfin PDT
Outcomes Primary outcome measure:
  • change from baseline BCVA to the mean level of BCVA (letters) over all monthly post‐baseline assessments (time frame: month 1 to month 3).


Secondary outcome measures:
  • mean level of BCVA (letters); BCVA change (time frame: month 1 to month 6);

  • mean level of BCVA (letters); BCVA change (time frame: 12 months);

  • improvement in BCVA (time frame: 12 months);

  • change in retinal thickness measured on OCT image by reading centre (time frame: 12 months);

  • CNV leakage presence measured on fluorescein angiography image by reading centre (time frame: 12 months);

  • quality of life (time frame: 12 months);

  • number of injections and period (time) between injections (time frame: 12 months);

  • occurrence and incidence of the adverse effects (time frame: 12 months).

Starting date September 2013
Contact information Novartis Pharmaceuticals +4163241111
Notes  

BCVA: best‐corrected visual acuity; CNV: choroidal neovascularisation; ETDRS: Early Treatment Diabetic Retinopathy Study; OCT: optical coherence tomography; PDT: photodynamic therapy.