A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

Allergan

Status and phase: Completed; Phase 2

Conditions: Macular Edema

Treatments: Drug: ranibizumab; Drug: abicipar pegol; Other: sham procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT02186119

PALM

150998-004

Details and patient eligibility

About

This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.

Enrollment: 151 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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151 participants in 4 patient groups

abicipar pegol 2 mg (group A)

Experimental group

Description:

Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.

Treatment:

Other: sham procedure

Drug: abicipar pegol

abicipar pegol 2 mg (group B)

Experimental group

Description:

Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.

Treatment:

Other: sham procedure

Drug: abicipar pegol

abicipar pegol 1 mg

Experimental group

Description:

Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.

Treatment:

Other: sham procedure

Drug: abicipar pegol

ranibizumab

Active Comparator group

Description:

Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.

Treatment:

Drug: ranibizumab