A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186119
• Other study ID #: 150998-004
• Secondary ID: PALM
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2014
• Last updated: July 10, 2015
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• 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 diabetic macular edema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of diabetes mellitus (Type 1 or 2)

• Decreased vision due to diabetic macular edema 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:

• Stroke or heart attack within the past 3 months

• History of vitrectomy, macular surgery, or glaucoma surgery in the study eye

• Cataract or refractive surgery in the study eye within the last 3 months

• Laser photocoagulation of the study eye within the last 3 months

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 Edema

Intervention

Drug:
• abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
• ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.

Other:
• sham procedure
Sham procedure to the study eye at the visits noted per protocol.

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)		Baseline, Week 28	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, 28 Weeks	No
Secondary	Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye		Baseline, Week 28	No
Secondary	Percentage of Patients with a BCVA of =70 Letters		28 Weeks	No
Secondary	Percentage of Patients with Resolution of Macular Edema		28 Weeks	No