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

Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181517
• Other study ID #: 150998-003
• Secondary ID: CYPRESS
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2014
• Last updated: January 14, 2016
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

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