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

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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

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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