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Allergan Sequoia
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration

Study Site: We are enrolling patients in this study at the SOUTH location

Inclusion Criteria:
  • Presence of active subfoveal and/or juxtafoveal CNV secondary to AMD with retinal fluid on optical coherence tomography (OCT) and/or fluorescein leakage under the fovea as assessed by the investigator at screening and confirmed by the central reading center prior to baseline
  • Area of the CNV lesion, including both classic and occult components, must be >50% of the total lesion area as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (Day 1)
  • BCVA < 73 and > 24 letters (20/40 to 20/320 Snellen equivalents, respectively)
  • BCVA of 34 letters (Snellen equivalent 20/200) in the non-study eye
Exclusion Criteria:
  • Treatment with systemic anti-VEGF, medication (e.g. bevacizumab, ziv-aflibercept) or VEGF-receptor inhibitor (e.g. sunitinib, sorafenib, pazopanib) within three months prior to baseline (Day 1)
  • Use of systemic (e.g. oral, intravenous, intramuscular, rectal or extensive dermal [>20% total body surface area]) corticosteroids within five days prior to baseline (Day 1)

Ocular Exclusion Criteria: (Either eye)

  • Active ocular/intraocular infection at baseline (Day 1)
  • History of recurrent or currently active ocular/intraocular inflammation (e.g. uveitis) at baseline (Day 1)
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME) or any retinal vascular disease other than AMD at screening
  • Presence of CNV other than AMD at screening (e.g. pathologic myopia, ocular histoplasmosis and angioid streaks)
  • Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD, approved or investigational, except dietary supplements or vitamins
  • Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD
  • Total lesion size > 12 disc area (DA) (30.5 mm2 including blood, neovascularization and fibrosis) as assessed by the investigator at screening and confirmed by the reading center prior to baseline (Day 1)
  • Macular scar or fibrosis, making up > 50% of total lesion area as assessed by the investigator at screening and confirmed by the central reading center prior to baseline
  • Uncontrolled glaucoma or ocular hypertension
Principal Investigator:

Dr. Gaurav K. Shah

Sub Investigators:

Dr. Kevin J. Blinder
Dr. Bradley T. Smith
Dr. Nicholas Chinskey
Dr. Vincent Ho
Dr. Yicheng Chen
Dr. Abdallah Jeroudi

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