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Completed

NCT Number: NCT02181504

A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration

This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nihon University Hospital, Chiyoda-ku,Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ethnically Japanese
  • Diagnosis of wet age-related macular degeneration 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

  • Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish
  • Cataract or refractive surgery within the last 3 months
  • History of vitrectomy

Treatment and study plan

Abicipar Pegol

Drug

Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.

ranibizumab

Drug

Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.

Other names: Lucentis®

Sham Procedure

Other

Sham procedure to the study eye at weeks 12 and 16.

Primary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, Week 16

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.

Secondary outcomes

  1. Change From Baseline in BCVA in the Study Eye

    Time frame: Baseline, Week 20

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.

  2. 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, 20 Weeks

    BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥15 letters are noted.

  3. Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale

    Time frame: Baseline, 20 Weeks

    BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥10 letters are noted.

  4. Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Time frame: Baseline, Week 16, Week 20

    CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 4, 2014
Registry last updated
Apr 25, 2017

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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