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A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration (CDER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02462928
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE June 2, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE June 25, 2015
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye [ Time Frame: Baseline, Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02462928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Week 52 ]
  • Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline, Week 52 ]
  • Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale [ Time Frame: Baseline, Week 52 ]
  • Change from Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score [ Time Frame: Baseline, Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Official Title  ICMJE Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration
Brief Summary This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE
  • Drug: abicipar pegol
    Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
  • Drug: ranibizumab
    Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.
    Other Name: Lucentis®
  • Other: sham procedure
    Sham procedure to the study eye at the visits noted per protocol.
Study Arms  ICMJE
  • Experimental: abicipar pegol 2 mg (group A)
    Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 8, followed by injections every 8 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.
    Interventions:
    • Drug: abicipar pegol
    • Other: sham procedure
  • Experimental: abicipar pegol 2 mg (group B)
    Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 12, followed by injections every 12 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.
    Interventions:
    • Drug: abicipar pegol
    • Other: sham procedure
  • Active Comparator: ranibizumab
    Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.
    Intervention: Drug: ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2018)
939
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2015)
900
Actual Study Completion Date  ICMJE June 19, 2019
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of age-related macular degeneration in at least 1 eye
  • Best corrected visual acuity of 20/40 to 20/320 in the study eye
  • Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion Criteria:

  • History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
  • Cataract or refractive surgery in the study eye within the last 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Chile,   Colombia,   Czechia,   France,   Germany,   Hong Kong,   Israel,   Korea, Republic of,   Latvia,   New Zealand,   Philippines,   Singapore,   Spain,   Switzerland,   United States
Removed Location Countries Czech Republic,   Portugal
 
Administrative Information
NCT Number  ICMJE NCT02462928
Other Study ID Numbers  ICMJE 150998-005
2014-004579-22 ( EudraCT Number )
CEDAR ( Other Identifier: Allergan )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joanne Li Allergan
PRS Account Allergan
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP