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Trial record 1 of 1 for:    NCT02181504
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A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT02181504
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: abicipar pegol Drug: ranibizumab Other: sham procedure Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: abicipar pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.

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

Experimental: abicipar pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.

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

Active Comparator: ranibizumab 0.5 mg
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Drug: ranibizumab
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Other Name: Lucentis®




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181504


Locations
Japan
Nihon University Hospital
Chiyoda-ku,Tokyo, Japan, 101-8309
1 Fukushima Medical University
Fukushima-shi, Japan, 960-1295
Kyushu University Hospital
Kita-ku, Fukuoka-shi Fukuoka, Japan, 812-8582
Okayama University Hospital
Kita-ku, Okayama-shi Okayama, Japan, 700-8558
Shiga University
Otsu-shi, Japan, 520-2192
Tokyo Women's Medical University
Shinjuku-ku, Japan, 162-8666
Nagoya University Hospital
Showa-ku, Nagoya-shi Aichi, Japan, 466-8560
Takeuchi Eye Clinic
Taito Ku Tokyo, Japan, 111-0051
Musashi Dream Clinic
Tennoji-ku Osaka, Japan, 543-0027
Juntendo University Urayas
Urayasu-shi, Japan, 279-0021
Otakeganka Tsukimino Clinic
Yamato Kanagawa, Japan, 242-0001
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02181504     History of Changes
Other Study ID Numbers: 150998-002
BAMBOO ( Other Identifier: Allergan )
First Posted: July 4, 2014    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents