Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
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| ClinicalTrials.gov Identifier: NCT00943072 |
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Recruitment Status :
Completed
First Posted : July 21, 2009
Results First Posted : May 27, 2013
Last Update Posted : May 27, 2013
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Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Macular Edema Secondary to Central Retinal Vein Occlusion | Biological: VEGF Trap-Eye 2.0mg Drug: Sham | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 189 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | April 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VEGF Trap-Eye
Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint
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Biological: VEGF Trap-Eye 2.0mg
Monthly intravitreal injection out to the Week 24 Primary endpoint |
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Sham Comparator: Sham
Monthly Sham IVT injection until Week 24 Primary Endpoint
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Drug: Sham
Monthly sham intravitreal injection out to Week 24 Primary Endpoint |
Primary Outcome Measures :
- Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score [ Time Frame: Baseline and at Week 24 ]
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Secondary Outcome Measures :
- Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and at Week 24 ]Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
- Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: Baseline and at Week 24 ]
- 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 [ Time Frame: Baseline to Week 24 ]
- Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF) [ Time Frame: Baseline and at Week 24 ]The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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): NCT00943072
Locations
Show 61 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00943072 |
| Other Study ID Numbers: |
VGFT-OD-0819 |
| First Posted: | July 21, 2009 Key Record Dates |
| Results First Posted: | May 27, 2013 |
| Last Update Posted: | May 27, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Regeneron Pharmaceuticals:
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Macular edema Retinal vein occlusion CRVO VEGF Trap-Eye |
best-corrected visual acuity Regeneron COPERNICUS |
Additional relevant MeSH terms:
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Neoplasm Metastasis Macular Edema Retinal Vein Occlusion Edema Neoplastic Processes Neoplasms Pathologic Processes Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis |
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Aflibercept Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |