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

NCT02181504 | Completed Phase 2 Results DMC

• 2 other identifiers: 150998-002BAMBOO
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 11

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.

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, Week 16

Secondary Outcomes (4)

• Change From Baseline in BCVA in the Study Eye

  Baseline, Week 20

• Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale

  Baseline, 20 Weeks

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

  Baseline, 20 Weeks

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

  Baseline, Week 16, Week 20

Study Arms (3)

abicipar pegol 2 mg

EXPERIMENTAL

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; Other: sham procedure

abicipar pegol 1 mg

EXPERIMENTAL

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; Other: sham procedure

ranibizumab 0.5 mg

ACTIVE COMPARATOR

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

Drug: ranibizumab

Interventions

abicipar pegol DRUG

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

abicipar pegol 1 mg; abicipar pegol 2 mg

ranibizumab DRUG

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

Also known as: Lucentis®

ranibizumab 0.5 mg

sham procedure OTHER

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

abicipar pegol 1 mg; abicipar pegol 2 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (11)

Nihon University Hospital

Chiyoda-ku,Tokyo, 101-8309, Japan

Location

1 Fukushima Medical University

Fukushima, 960-1295, Japan

Location

Kyushu University Hospital

Kita-ku, Fukuoka-shi Fukuoka, 812-8582, Japan

Location

Okayama University Hospital

Kita-ku, Okayama-shi Okayama, 700-8558, Japan

Location

Shiga University

Ōtsu, 520-2192, Japan

Location

Tokyo Women's Medical University

Shinjuku-ku, 162-8666, Japan

Location

Nagoya University Hospital

Showa-ku, Nagoya-shi Aichi, 466-8560, Japan

Location

Takeuchi Eye Clinic

Taito Ku Tokyo, 111-0051, Japan

Location

Musashi Dream Clinic

Tennoji-ku Osaka, 543-0027, Japan

Location

Juntendo University Urayas

Urayasu-shi, 279-0021, Japan

Location

Otakeganka Tsukimino Clinic

Yamato Kanagawa, 242-0001, Japan

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

abicipar pegol; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 2, 2014
• First Posted: July 4, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-03

Locations

JP (11)