Phase 3
N=189
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Macular Edema Secondary to Central Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT00943072 ↗Enrolled (actual)
189
Serious AEs
12.9%
Results posted
May 2013
Primary outcome: Primary: Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score — 64; 9 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VEGF Trap-Eye 2.0mg (Biological); Sham (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score |
64; 9 | < 0.0001 sig |
| SECONDARY Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF) |
17.3; -4.0 | < 0.0001 sig |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF |
-457.2; -144.8 | < 0.0001 sig |
| SECONDARY Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks |
0; 6.8; 0; 6.8; 0; 0 | 0.0059 sig |
| SECONDARY Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF) |
7.2; 0.8 | 0.0009 sig |
Summary
This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.
Eligibility Criteria
Inclusion Criteria
- Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
- ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye
Exclusion Criteria
- Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
- Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
- CRVO disease duration > 9 months from date of diagnosis
- Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
- Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
Data sourced from ClinicalTrials.gov (NCT00943072). 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.