Phase 3
N=177
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01012973 ↗Enrolled (actual)
177
Serious AEs
9.4%
Results posted
Nov 2012
Primary outcome: Primary: Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures — 60.2; 22.1 Percentage of participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) (Biological); Sham treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures |
60.2; 22.1 | <.0001 sig |
| SECONDARY Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF) |
71.6; 54.3 | <.0001 sig |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF |
-448.58; -169.27 | <.0001 sig |
| SECONDARY Percentage of Participants Who Developed Neovascularization During the First 24 Weeks |
2.9; 4.4; 1.9; 1.5; 0.0; 0.0 | 0.5947 |
| SECONDARY Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF |
7.46; 3.55 | — |
| SECONDARY Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF |
0.029; -0.002 | — |
Summary
To determine the efficacy of vascular endothelial growth factor (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
- Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (OCT)
- Adults ≥ 18 years
- Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
Exclusion Criteria
- Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
- 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 (NCT01012973). 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.