BRVO // Clinical Trials // Macular Edema // Michael Altaweel // Ongoing // Retinal Vein Occlusion // Jun 12 2019

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients with Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (RAPTOR)

  • Sponsor: Novartis Pharmaceuticals
  • Principal Investigator: Michael Altaweel, MD
  • Study Coordinator: Angie Adler

Study objective:

To evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema secondary to branch retinal vein occlusion.

Study design:

After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects will enter a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an active or a sham injection. Maximum study duration is 80 weeks.

Inclusion criteria:

  • Patients with visual impairment due to ME secondary to BRVO diagnosed < 6 months prior to screening
  • BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits

Exclusion criteria:

  • Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
  • Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator’s judgment, at screening or baseline
  • Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)
  • Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline
  • Previous use of intraocular or periocular steroids in study eye at any time prior to baseline
  • Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline
  • Intraocular surgery in the study eye during the 3-month period prior to baseline
  • Vitreoretinal surgery in the study eye at any time prior to baseline
  • Aphakia with the absence of posterior capsule in the study eye

Contact Angie Adler with questions: 608-265-7557. For more information about this study: visit clinicaltrials.govĀ