Back to resultsA Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Primary Purpose
Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
abicipar pegol
ranibizumab
sham procedure
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of wet age-related macular degeneration in at least 1 eye
- Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Exclusion Criteria:
- Hypersensitivity, allergy, or anaphylactic reaction to iodine
- Cataract or refractive surgery within the last 3 months
- History of vitrectomy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
abicipar pegol 1 mg
abicipar pegol 2 mg
ranibizumab 0.5 mg
Arm Description
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Outcomes
Primary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Secondary Outcome Measures
Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02181517
Brief Title
A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abicipar pegol 1 mg
Arm Type
Experimental
Arm Description
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
Arm Title
abicipar pegol 2 mg
Arm Type
Experimental
Arm Description
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
Arm Title
ranibizumab 0.5 mg
Arm Type
Active Comparator
Arm Description
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Intervention Type
Drug
Intervention Name(s)
abicipar pegol
Intervention Description
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Intervention Type
Other
Intervention Name(s)
sham procedure
Intervention Description
Sham procedure to the study eye at weeks 12 and 16.
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Week 20
Title
Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Week 20
Title
Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Week 20
Title
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Description
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Time Frame
Baseline, Week 16, Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of wet age-related macular degeneration in at least 1 eye
Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Exclusion Criteria:
Hypersensitivity, allergy, or anaphylactic reaction to iodine
Cataract or refractive surgery within the last 3 months
History of vitrectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
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