NCT02186119

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

July 8, 2014

Last Update Submit

July 10, 2015

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Best Corrected Visual Acuity (BCVA)

    Baseline, Week 28

Secondary Outcomes (4)

  • 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

Study Arms (4)

abicipar pegol 2 mg (group A)

EXPERIMENTAL

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 pegolOther: sham procedure

abicipar pegol 2 mg (group B)

EXPERIMENTAL

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 pegolOther: sham procedure

abicipar pegol 1 mg

EXPERIMENTAL

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 pegolOther: sham procedure

ranibizumab

ACTIVE COMPARATOR

Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.

Drug: ranibizumab

Interventions

abicipar pegolDRUG

Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.

abicipar pegol 1 mgabicipar pegol 2 mg (group A)abicipar pegol 2 mg (group B)
ranibizumabDRUG

Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.

Also known as: Lucentis®
ranibizumab
sham procedureOTHER

Sham procedure to the study eye at the visits noted per protocol.

abicipar pegol 1 mgabicipar pegol 2 mg (group A)abicipar pegol 2 mg (group B)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Gilbert, Arizona, United States

Location

Unknown Facility

Abilene, Texas, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

abicipar pegolRanibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

US(2)