A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
NCT ID: NCT02186119
Last Updated: 2015-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2014-07-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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abicipar pegol 2 mg (group A)
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
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
sham procedure
Sham procedure to the study eye at the visits noted per protocol.
abicipar pegol 2 mg (group B)
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
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
sham procedure
Sham procedure to the study eye at the visits noted per protocol.
abicipar pegol 1 mg
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.
abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
sham procedure
Sham procedure to the study eye at the visits noted per protocol.
ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Interventions
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abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
sham procedure
Sham procedure to the study eye at the visits noted per protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Gilbert, Arizona, United States
Abilene, Texas, United States
Countries
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Other Identifiers
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PALM
Identifier Type: OTHER
Identifier Source: secondary_id
150998-004
Identifier Type: -
Identifier Source: org_study_id
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