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

Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181504
• Other study ID #: 150998-002
• Secondary ID: BAMBOO
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2014
• Last updated: December 18, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
• ranibizumab
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.

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

Locations

Country	Name	City	State
Japan	Nihon University Hospital	Chiyoda-ku,Tokyo
Japan	1 Fukushima Medical University	Fukushima-shi
Japan	Kyushu University Hospital	Kita-ku, Fukuoka-shi Fukuoka
Japan	Okayama University Hospital	Kita-ku, Okayama-shi Okayama
Japan	Shiga University	Otsu-shi
Japan	Tokyo Women's Medical University	Shinjuku-ku
Japan	Nagoya University Hospital	Showa-ku, Nagoya-shi Aichi
Japan	Takeuchi Eye Clinic	Taito Ku Tokyo
Japan	Musashi Dream Clinic	Tennoji-ku Osaka
Japan	Juntendo University Urayas	Urayasu-shi
Japan	Otakeganka Tsukimino Clinic	Yamato Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye		Baseline, Week 16	No
Secondary	Change from Baseline in BCVA in the Study Eye		Baseline, Week 20	No
Secondary	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	No
Secondary	Percentage of Patients with a BCVA Gain of =10 Letters in the Study Eye on the ETDRS Scale		Baseline, 20 Weeks	No
Secondary	Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye		Baseline, Week 16, Week 20	No
Secondary	Serum Levels of Abicipar		20 Weeks	No

External Links

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