Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

Study Description

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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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: VEGF Trap-Eye; Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint	Biological: VEGF Trap-Eye 2.0mg; Monthly intravitreal injection out to the Week 24 Primary endpoint
Sham Comparator: Sham; Monthly Sham IVT injection until Week 24 Primary Endpoint	Drug: Sham; Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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.
2. Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: Baseline and at Week 24 ]
3. 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 ]
4. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 61 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

Bayer

Investigators

Study Director:	Clinical Trial Management	Regeneron Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00943072 History of Changes
Other Study ID Numbers:	VGFT-OD-0819
First Posted:	July 21, 2009
Results First Posted:	May 27, 2013
Last Update Posted:	May 27, 2013
Last Verified:	April 2013

Keywords provided by Regeneron Pharmaceuticals:

Macular edema; Retinal vein occlusion; CRVO; VEGF Trap-Eye	best-corrected visual acuity; Regeneron; COPERNICUS

Additional relevant MeSH terms:

Neoplasm Metastasis; Edema; Macular Edema; Retinal Vein Occlusion; Neoplastic Processes; Neoplasms; Pathologic Processes; Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases	Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Mitogens; Endothelial Growth Factors; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Growth Substances; Physiological Effects of Drugs