Ophthalmology and Visual Sciences

PULSAR

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Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients with Neovascular Age-Related Macular Degeneration (PULSAR)

  • Sponsor: Bayer
  • Principal Investigator: Mihai Mititelu, MD, MPH
  • Study Coordinator: Angie Adler

Study objective:

To learn more about changes in visual acuity (clarity of vision) with a high dose treatment of Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration.

Study design:

The study duration is approximately 2 years. Participants will receive aflibercept 2 mg every 8 weeks, aflibercept 8 mg every 12 weeks or aflibercept 8 mg every 16 weeks, after 3 initial injections at 4-week intervals.

Inclusion criteria:

  • Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye
  • Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye
  • BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye
  • Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.

Exclusion criteria:

  • Causes of CNV other than nAMD in the study eye
  • Scar, fibrosis, or atrophy involving the central subfield in the study eye
  • Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye
  • Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye
  • History of idiopathic or autoimmune uveitis in the study eye
  • Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye
  • Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg)

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