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Completed

NCT Number: NCT01027650

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

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.

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Key information

Conditions

Macular Edema Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

East Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGN208397 intravitreal injection

Drug

AGN208397 intravitreal injection on Day 1.

dexamethasone Intravitreal Implant

Drug

Dexamethasone 700 ug intravitreal implant on Day 1.

Other names: Ozurdex®

Primary outcomes

  1. Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1

    Time frame: Baseline, Month 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.

  2. Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2

    Time frame: Baseline, Month 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.

  3. Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1

    Time frame: Baseline, Month 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.

  4. Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2

    Time frame: Baseline, Month 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.

Secondary outcomes

  1. Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1

    Time frame: Baseline, Month 12

    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.

  2. Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2

    Time frame: Baseline, Month 12

    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.

  3. Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1

    Time frame: Baseline, Month 12

    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.

  4. Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2

    Time frame: Baseline, Month 12

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 8, 2009
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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