Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

Study Identifier
150998-001
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Macular Degeneration - Other
  • Study Drug
  • AGN-150998
  • ranibizumab
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    50+ years

    Protocol Summary

    This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

    Study Locations

    Location
    Status
    Location
    Phoenix, Arizona, United States
    Status
    Not applicable
    Location
    Sydney, New South Wales, Australia
    Status
    Not applicable
    Location
    Vienna, Austria
    Status
    Not applicable
    Location
    Créteil, France
    Status
    Not applicable
    Location
    Bonn, Germany
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable
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