A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

Phase 2

Completed

• Conditions: Macular Edema
• Interventions: Drug: ranibizumab; Drug: abicipar pegol; Other: sham procedure

• 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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-14

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