A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
Phase 2
Completed
- Conditions
- Macular Edema
- Interventions
- Registration Number
- NCT02186119
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description abicipar pegol 2 mg (group A) sham procedure 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 (group B) sham procedure 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 sham procedure 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 ranibizumab Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. abicipar pegol 1 mg abicipar pegol 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 2 mg (group A) abicipar pegol 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 (group B) abicipar pegol 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Best Corrected Visual Acuity (BCVA) Baseline, Week 28
- Secondary Outcome Measures
Name Time Method Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale Baseline, 28 Weeks Percentage of Patients with a BCVA of ≥70 Letters 28 Weeks Percentage of Patients with Resolution of Macular Edema 28 Weeks Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye Baseline, Week 28