Phase 2
N=121
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01027650 ↗Enrolled (actual)
121
Serious AEs
12.4%
Results posted
Apr 2014
Primary outcome: Primary: Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 — 500.2; 495.8; 499.5; 468.3 Microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN208397 intravitreal injection (Drug); dexamethasone intravitreal implant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 |
500.2; 495.8; 499.5; 468.3; -234.3; -210.5 | — |
| PRIMARY Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 |
612.6; 637.8; 597.9; 679.7; -298.5; -314.1 | — |
| PRIMARY Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 |
54.5; 50.2; 59.7; 53.0; 10.0; 11.7 | — |
| PRIMARY Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 |
49.5; 47.6; 58.2; 50.5; 12.0; 12.5 | — |
| SECONDARY Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 |
500.2; 495.8; 499.5; 468.3; -221.7; -173.0 | — |
| SECONDARY Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 |
612.6; 637.8; 597.9; 679.7; -252.8; -218.0 | — |
| SECONDARY Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 |
54.5; 50.2; 59.7; 53.0; 14.2; 0.8 | — |
| SECONDARY Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 |
49.5; 47.6; 58.2; 50.5; 8.0; 10.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01027650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.