Back to resultsA Study of Abicipar Pegol in Patients With Diabetic Macular Edema
Primary Purpose
Macular Edema
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 Edema
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetes mellitus (Type 1 or 2)
- Decreased vision due to diabetic macular edema 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:
- Stroke or heart attack within the past 3 months
- 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
- Laser photocoagulation of the study eye within the last 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
abicipar pegol 2 mg (group A)
abicipar pegol 2 mg (group B)
abicipar pegol 1 mg
ranibizumab
Arm Description
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Outcomes
Primary Outcome Measures
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Secondary Outcome Measures
Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
Percentage of Patients with a BCVA of ≥70 Letters
Percentage of Patients with Resolution of Macular Edema
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02186119
Brief Title
A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 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 diabetic macular edema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abicipar pegol 2 mg (group A)
Arm Type
Experimental
Arm Description
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.
Arm Title
abicipar pegol 2 mg (group B)
Arm Type
Experimental
Arm Description
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
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, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
Arm Title
ranibizumab
Arm Type
Active Comparator
Arm Description
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Intervention Type
Drug
Intervention Name(s)
abicipar pegol
Intervention Description
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Intervention Type
Other
Intervention Name(s)
sham procedure
Intervention Description
Sham procedure to the study eye at the visits noted per protocol.
Primary Outcome Measure Information:
Title
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Time Frame
Baseline, Week 28
Secondary Outcome Measure Information:
Title
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, 28 Weeks
Title
Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time Frame
Baseline, Week 28
Title
Percentage of Patients with a BCVA of ≥70 Letters
Time Frame
28 Weeks
Title
Percentage of Patients with Resolution of Macular Edema
Time Frame
28 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of diabetes mellitus (Type 1 or 2)
Decreased vision due to diabetic macular edema 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:
Stroke or heart attack within the past 3 months
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
Laser photocoagulation of the study eye within the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Gilbert
State/Province
Arizona
Country
United States
City
Abilene
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
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