Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)

Allergan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: dexamethasone intravitreal implant; Drug: AGN208397 intravitreal injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01027650

208397-001

Details and patient eligibility

About

This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• macular edema due to retinal vein occlusion
• visual acuity in the study eye between 20/320 to 20/40

Exclusion criteria

• cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
• use of injectable drugs in the study eye within 2 months prior to day 1
• active eye infection in either eye
• visual acuity in the non-study eye of 20/200 or worse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 8 patient groups

Stage 1 Cohort 1

Experimental group

Description:

AGN208397 intravitreal injection 75 ug on Day 1.

Treatment:

Drug: AGN208397 intravitreal injection

Stage 1 Cohort 2

Experimental group

Description:

AGN208397 intravitreal injection 300 ug on Day 1.

Treatment:

Drug: AGN208397 intravitreal injection

Stage 1 Cohort 3

Experimental group

Description:

AGN208397 intravitreal injection 600 ug on Day 1.

Treatment:

Drug: AGN208397 intravitreal injection

Stage 1 Cohort 4

Experimental group

Description:

AGN208397 intravitreal injection 900 ug on Day 1.

Treatment:

Drug: AGN208397 intravitreal injection

Stage 2 Arm 1

Experimental group

Description:

AGN208397 intravitreal injection 600 ug on Day 1.

Treatment:

Drug: AGN208397 intravitreal injection

Stage 2 Arm 2

Experimental group

Description:

AGN208397 intravitreal injection 450 ug on Day 1.

Treatment:

Drug: AGN208397 intravitreal injection

Stage 2 Arm 3

Experimental group

Description:

AGN208397 intravitreal injection 300 ug on Day 1.

Treatment:

Drug: AGN208397 intravitreal injection

Stage 2 Arm 4

Active Comparator group

Description:

Dexamethasone 700 ug intravitreal implant on Day 1.

Treatment:

Drug: dexamethasone intravitreal implant