Macular Edema
Conditions
Brief summary
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
Interventions
DRUGabicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
DRUGranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
OTHERsham procedure
Sham procedure to the study eye at the visits noted per protocol.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Best Corrected Visual Acuity (BCVA) | Baseline, Week 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline, Week 28 |
| Percentage of Patients with a BCVA of ≥70 Letters | 28 Weeks |
| Percentage of Patients with Resolution of Macular Edema | 28 Weeks |
Countries
United States
Outcome results
None listed