April 2014
Volume 55, Issue 13
ARVO Annual Meeting Abstract  |   April 2014
Ranibizumab ±adjunctive laser vs laser in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO): Design and baseline characteristics of the BRIGHTER study
Author Affiliations & Notes
  • Heinrich Gerding
    University of Muenster, Muenster, Germany
  • Francesco Boscia
    University of Sassari, Sassari, Italy
  • Jordi M Mones
    Barcelon Macula foundataion, Barcelona, Spain
  • Siegfried Priglinger
    AKh Linz - General Hospital, Krankenhausstrae 9, Austria
  • Ramin Tadayoni
    Hopital Lariboisiere, Paris, France
  • Jackie Han
    Novartis Pharma AG, Basel, Switzerland
  • George Lambrou
    Novartis Pharma AG, Basel, Switzerland
  • William John Stubbings
    Novartis Pharma AG, Basel, Switzerland
  • Ian A Pearce
    Royal Liverpool University Hospital, Liverpool, United Kingdom
  • Footnotes
    Commercial Relationships Heinrich Gerding, Allergan (C), Bayer (C), Bayer (R), ESBA Tech (C), Heidelberg Engineering (R), Novartis (C), Novartis (R); Francesco Boscia, Alcon (R), Allergan (R), Bayer (R), Novartis (C), Novartis (R); Jordi Mones, Alcon (C), Allergan (C), Bayer (C), Notalvision (C), Novartis (C), Ophthotech (C); Siegfried Priglinger, Bausch and Lomb (R), Bayer (R), Novartis (C), Novartis (R), Ortli (C); Ramin Tadayoni, Alcon (C), Alcon (R), Alimera (R), Allergan (C), Allergan (R), Bausch & Lomb (C), Bausch & Lomb (R), Bayer (R), DORC (C), FCI-Zeiss (C), Novartis (C), Novartis (R), Pfeizer (R), Takeda (C), Takeda (R), Thrombogenics (C), Thrombogenics (R); Jackie Han, Novartis (E); George Lambrou, Novartis (E); William John Stubbings, Novartis (E); Ian Pearce, Bayer (C), Bayer (R), Novartis (C), Novartis (R)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 607. doi:
  • Views
  • Share
  • Tools
    • Alerts
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Heinrich Gerding, Francesco Boscia, Jordi M Mones, Siegfried Priglinger, Ramin Tadayoni, Jackie Han, George Lambrou, William John Stubbings, Ian A Pearce; Ranibizumab ±adjunctive laser vs laser in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO): Design and baseline characteristics of the BRIGHTER study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):607.

      Download citation file:

      © ARVO (1962-2015); The Authors (2016-present)

  • Supplements

Purpose: The BRIGHTER study was designed to compare an individualized, stabilization-criteria driven pro re nata (PRN) dosing regimen of ranibizumab (RBZ) 0.5mg (±adjunctive laser) vs laser photocoagulation up to Month (M) 6 and then to evaluate its long-term (24M) efficacy and safety in patients with visual impairment due to macular edema (ME) secondary to BRVO. Here, we describe the study design and baseline characteristics of enrolled patients.

Methods: In this ongoing 24M, phase IIIb, open-label, active-controlled, three-arm, multicenter study, patients were randomized 2:2:1 to RBZ alone (G1), RBZ+laser (G2) or laser alone (G3) groups. Patients in G1 and G2 received monthly RBZ 0.5mg until visual acuity (VA) stabilization and PRN thereafter. Laser was applied to patients with perfused ME in G2 and G3 (PRN based on physicians assessment). After M6, G3 patients can receive RBZ. All patients are monitored monthly up to M12 and can be every 2M thereafter, dependent on stable VA and absence of disease activity. Key objectives: superiority of RZB 0.5mg±laser vs laser at M6 (primary endpoint); non-inferiority of RBZ+laser vs RBZ alone (to M24) and, if successful, evaluate the impact of laser in reducing the number of RBZ retreatments up to M23.

Results: 455 patients (mean age 66.3 years, 50.3% female) were enrolled from 81 sites in Europe, Australia and Canada. Baseline ocular characteristics are as follows—mean baseline BCVA: 57.6 (±12.9, SD) letters; mean intraocular pressure (IOP): 15.3 (±2.8, SD) mmHg; prior duration of BRVO (median): 3M and 25.1% patients had retinal ischemia (according to the judgment of investigator).The most frequent medical history findings were hypertension (n=274), hypercholesterolemia (n=101), cataract/cataract operation (n=95) and hyperlipidemia (n=47).

Conclusions: The study population was comparable to the pivotal BRAVO study in terms of age, gender, and mean baseline IOP and prior duration of BRVO. Differences to BRAVO included higher mean baseline BCVA (58 vs 53 letters) and possibly a higher proportion of ischemic patients (25% vs. 0%), although this was assessed by the investigators and not by the Central Reading Center. The patients enrolled in the BRIGHTER study are well suited to investigate the long-term safety and efficacy of RBZ (±adjunctive laser) in BRVO.

Keywords: 585 macula/fovea • 505 edema • 748 vascular endothelial growth factor  

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.