A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

Study Overview
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Brief Summary
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This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: abicipar pegol
* Drug: ranibizumab
* Other: sham procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abicipar pegol 2 mg (group A)<br>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. | Drug: abicipar pegol<br>* Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.<br>Other: sham procedure<br>* Sham procedure to the study eye at the visits noted per protocol.<br>|
| Experimental: abicipar pegol 2 mg (group B)<br>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. | Drug: abicipar pegol<br>* Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.<br>Other: sham procedure<br>* Sham procedure to the study eye at the visits noted per protocol.<br>|
| Experimental: abicipar pegol 1 mg<br>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. | Drug: abicipar pegol<br>* Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.<br>Other: sham procedure<br>* Sham procedure to the study eye at the visits noted per protocol.<br>|
| Active Comparator: ranibizumab<br>Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. | Drug: ranibizumab<br>* Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.<br>* Other names: Lucentis®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Best Corrected Visual Acuity (BCVA) |  | Baseline, Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |