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Allergan SEQUOIA / CEDAR Study

TRIAL DESCRIPTION SUMMARY:

Patients newly diagnosed with wet macular degeneration in either eye, which has not yet been treated, may be eligible for this research clinical trial using the study medication Abicipar Pegol.  Leading scientists have designed Abicipar to last longer than current treatments on the market.  So the objective of this study is to learn if Abicipar given at 8 or 12 week intervals is as effective and well-tolerated as Lucentis given monthly. 

BASIC TRIAL INFORMATION:


Phase:        III
Disease:     Newly Diagnosed, Not-Yet Treated Wet AMD
Age:           50 Years or Older
Sponsor:    Allergan
Status:       Currently Enrolling
Length:      2 Years


ELEGIBILITY CRITERIA:


Key Ocular Inclusion Criteria:

  1. Presence of active subfoveal and/or juxtafoveal CNV (1 to 200 micron from the center).
  2. Presence of retinal fluid on OCT and/or FA with leakage under the fovea.
  3. Area of the CNV lesion, including both classic and occult components, must be > 50% of the total lesion area.
  4. Visual acuity (BCVA) of 20/40 to 20/320.
  5. Visual acuity (BCVA) of 20/200 or better in the Non-study Eye.

Key Exclusion Criteria:

  1. Any prior PDT, radiation, or ocular treatment (including surgery) for wet AMD except dietary supplements.
  2. Treatment with ocular corticosteroid injections within 6 months or Iluvien within 36.
  3. Macular hemorrhage involving the center of the fovea if it is > 50% of the total lesion.
  4. Macular scar or fibrosis making up > 50% of total lesion.
  5. Structural damage likely to interfere with Visual Acuity.
  6. Currently taking systemic corticosteroids.
  7. Other inclusion/exclusion criteria apply to be screened by the Study Coordinator listed below.
     

STUDY TITLE: 

Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration.

TRIAL CONTACT INFORMATION:


Sites:  Beachwood and Youngstown
Study Coordinator:  John Lacombe
Email: jlacombe@retina-assoc.com
Phone: 216-831-5700