Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
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ClinicalTrials.gov Identifier: NCT01027650 |
Recruitment Status :
Completed
First Posted : December 8, 2009
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Macular Edema Retinal Vein Occlusion | Drug: AGN208397 intravitreal injection Drug: dexamethasone intravitreal implant | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 121 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | February 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
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Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1. |
Experimental: Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
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Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1. |
Experimental: Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
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Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1. |
Experimental: Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
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Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1. |
Experimental: Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
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Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1. |
Experimental: Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
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Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1. |
Experimental: Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
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Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1. |
Active Comparator: Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
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Drug: dexamethasone intravitreal implant
Dexamethasone 700 ug intravitreal implant on Day 1.
Other Name: Ozurdex® |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027650
United States, Arizona | |
Phoenix, Arizona, United States | |
Australia, Victoria | |
East Melbourne, Victoria, Australia | |
Canada, Ontario | |
London, Ontario, Canada | |
Israel | |
Tel Aviv, Israel | |
South Africa | |
Cape Town, South Africa |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01027650 |
Other Study ID Numbers: |
208397-001 |
First Posted: | December 8, 2009 Key Record Dates |
Results First Posted: | April 29, 2014 |
Last Update Posted: | April 29, 2014 |
Last Verified: | March 2014 |
Macular Edema Retinal Vein Occlusion Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Dexamethasone Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |