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Completed

NCT Number: NCT02186119

A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

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

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gilbert, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abicipar Pegol

Drug

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

ranibizumab

Drug

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

Other names: Lucentis®

Sham Procedure

Other

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

Primary outcomes

  1. Change from Baseline in Best Corrected Visual Acuity (BCVA)

    Time frame: Baseline, Week 28

Secondary outcomes

  1. 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

  2. Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Time frame: Baseline, Week 28

  3. Percentage of Patients with a BCVA of ≥70 Letters

    Time frame: 28 Weeks

  4. Percentage of Patients with Resolution of Macular Edema

    Time frame: 28 Weeks

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2014
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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