QUASAR

 

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion

• Sponsor: Bayer AG
• Principal Investigator: Mihai Mititelu
• Study Coordinator: Angie Adler

Study Objective:

To learn how well a higher amount of aflibercept works in people with macular edema secondary to retinal vein occlusion (RVO).

Study Design:

Depending on the treatment group, participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks.

Inclusion Criteria:

• Adults ≥18 years of age at the time of signing the informed consent
• Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks of the screening visit
• ETDRS BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits
• Mean CST ≥300 μm on optical coherence tomography (OCT) if excluding Bruch’s membrane (e.g., Cirrus or Topcon) or ≥320 μm if including Bruch’s membrane (e.g., Heidelberg Spectralis)

Exclusion Criteria:

• Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg) at the screening visit or baseline visit.
• Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) >12% at the screening visit.
• History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) before the screening visit or between screening and baseline visits.
• Renal failure requiring dialysis, or renal transplant at screening or potentially during the study.
• Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye.
• Previous administration of systemic anti-angiogenic medications for any condition.
• Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures:
  1. Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies).
  2. Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time.
  3. Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time.
  4. Treatment with ocriplasmin at any time.
  5. Vitreoretinal surgery (including scleral buckling) at any time.
  6. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit.
  7. Previous treatment with retinal laser photocoagulation.

Contact Angie Adler with questions, (608) 265-7557

For more information about this study, visit clinicaltrials.gov: https://clinicaltrials.gov/study/NCT05850520?term=Quasar&cond=Retinal%20Vein%20Occlusion&rank=1