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)
Principal Investigator: Mihai Mititelu, MD, MPH
Study Coordinator: Angie Adler
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.
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.
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.
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)