A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

July 10, 2015 updated by: Allergan
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States
    • Texas
      • Abilene, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
Other: sham procedure
Sham procedure to the study eye at the visits noted per protocol.
Experimental: 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.
Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
Other: sham procedure
Sham procedure to the study eye at the visits noted per protocol.
Experimental: 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.
Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
Other: sham procedure
Sham procedure to the study eye at the visits noted per protocol.
Active Comparator: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Drug: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Other Names:
  • Lucentis®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: Baseline, 28 Weeks
Baseline, 28 Weeks
Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time Frame: Baseline, Week 28
Baseline, Week 28
Percentage of Patients with a BCVA of ≥70 Letters
Time Frame: 28 Weeks
28 Weeks
Percentage of Patients with Resolution of Macular Edema
Time Frame: 28 Weeks
28 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150998-004
  • PALM (Allergan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macular Edema

Clinical Trials on abicipar pegol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe