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

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AGN208397 intravitreal injection
dexamethasone intravitreal implant
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Stage 1 Cohort 1

Stage 1 Cohort 2

Stage 1 Cohort 3

Stage 1 Cohort 4

Stage 2 Arm 1

Stage 2 Arm 2

Stage 2 Arm 3

Stage 2 Arm 4

Arm Description

AGN208397 intravitreal injection 75 ug on Day 1.

AGN208397 intravitreal injection 300 ug on Day 1.

AGN208397 intravitreal injection 600 ug on Day 1.

AGN208397 intravitreal injection 900 ug on Day 1.

AGN208397 intravitreal injection 600 ug on Day 1.

AGN208397 intravitreal injection 450 ug on Day 1.

AGN208397 intravitreal injection 300 ug on Day 1.

Dexamethasone 700 ug intravitreal implant on Day 1.

Outcomes

Primary Outcome Measures

Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Secondary Outcome Measures

Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Full Information

First Posted
December 4, 2009
Last Updated
March 27, 2014
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01027650
Brief Title
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 Cohort 1
Arm Type
Experimental
Arm Description
AGN208397 intravitreal injection 75 ug on Day 1.
Arm Title
Stage 1 Cohort 2
Arm Type
Experimental
Arm Description
AGN208397 intravitreal injection 300 ug on Day 1.
Arm Title
Stage 1 Cohort 3
Arm Type
Experimental
Arm Description
AGN208397 intravitreal injection 600 ug on Day 1.
Arm Title
Stage 1 Cohort 4
Arm Type
Experimental
Arm Description
AGN208397 intravitreal injection 900 ug on Day 1.
Arm Title
Stage 2 Arm 1
Arm Type
Experimental
Arm Description
AGN208397 intravitreal injection 600 ug on Day 1.
Arm Title
Stage 2 Arm 2
Arm Type
Experimental
Arm Description
AGN208397 intravitreal injection 450 ug on Day 1.
Arm Title
Stage 2 Arm 3
Arm Type
Experimental
Arm Description
AGN208397 intravitreal injection 300 ug on Day 1.
Arm Title
Stage 2 Arm 4
Arm Type
Active Comparator
Arm Description
Dexamethasone 700 ug intravitreal implant on Day 1.
Intervention Type
Drug
Intervention Name(s)
AGN208397 intravitreal injection
Intervention Description
AGN208397 intravitreal injection on Day 1.
Intervention Type
Drug
Intervention Name(s)
dexamethasone intravitreal implant
Other Intervention Name(s)
Ozurdex®
Intervention Description
Dexamethasone 700 ug intravitreal implant on Day 1.
Primary Outcome Measure Information:
Title
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Description
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time Frame
Baseline, Month 1
Title
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Description
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time Frame
Baseline, Month 1
Title
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Month 1
Title
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Month 1
Secondary Outcome Measure Information:
Title
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Description
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time Frame
Baseline, Month 12
Title
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Description
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time Frame
Baseline, Month 12
Title
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Month 12
Title
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame
Baseline, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
East Melbourne
State/Province
Victoria
Country
Australia
City
London
State/Province
Ontario
Country
Canada
City
Tel Aviv
Country
Israel
City
Cape Town
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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