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

NCT00943072 | Completed Phase 3 Results DMC

• 1 other identifier: VGFT-OD-0819
• Study Type: interventional
• Target: 189
• Locations: 5 countries
• Sites: 61

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.

Conditions

Macular Edema Secondary to Central Retinal Vein Occlusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score

  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.

  Baseline and at Week 24

Secondary Outcomes (4)

• Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)

  Baseline and at Week 24

• Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF

  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

  Baseline to Week 24

• Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)

  Baseline and at Week 24

Study Arms (2)

VEGF Trap-Eye

EXPERIMENTAL

Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint

Biological: VEGF Trap-Eye 2.0mg

Sham

SHAM COMPARATOR

Monthly Sham IVT injection until Week 24 Primary Endpoint

Drug: Sham

Interventions

VEGF Trap-Eye 2.0mg BIOLOGICAL

Monthly intravitreal injection out to the Week 24 Primary endpoint

VEGF Trap-Eye

Sham DRUG

Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Bayer: collaborator

Study Sites (61)

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Phoenix, Arizona, 85014, United States

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Phoenix, Arizona, 85020, United States

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Tucson, Arizona, 85704, United States

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Arcadia, California, 91007, United States

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Beverly Hills, California, 90211, United States

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La Jolla, California, 92037, United States

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Mountain View, California, 94040, United States

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Oakland, California, 94609, United States

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Sacramento, California, 95841, United States

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Torrance, California, 90503, United States

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New London, Connecticut, 06320, United States

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Altamonte Springs, Florida, 32701, United States

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Fort Lauderdale, Florida, 33334, United States

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Fort Myers, Florida, 33907, United States

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Fort Myers, Florida, 33912, United States

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Miami, Florida, 33143, United States

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Palm Beach Gardens, Florida, 33410, United States

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Winter Haven, Florida, 33880, United States

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Augusta, Georgia, 30909, United States

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Chicago, Illinois, 60612, United States

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Wichita, Kansas, 67214, United States

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Baltimore, Maryland, 21209, United States

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Hagerstown, Maryland, 21740, United States

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Towson, Maryland, 21204, United States

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Boston, Massachusetts, 02114, United States

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Grand Rapids, Michigan, 49525, United States

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Jackson, Michigan, 48104, United States

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Lincoln, Nebraska, 68506, United States

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Las Vegas, Nevada, 89135, United States

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Northfield, New Jersey, 08225, United States

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Toms River, New Jersey, 08755, United States

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Rochester, New York, 14620, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44195, United States

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Oklahoma City, Oklahoma, 73104, United States

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Portland, Oregon, 97210, United States

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Salem, Oregon, 97302, United States

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Kingston, Pennsylvania, 18704, United States

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Pittsburgh, Pennsylvania, 15213, United States

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West Columbia, South Carolina, 29169, United States

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Rapid City, South Dakota, 57701, United States

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Nashville, Tennessee, 37203, United States

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Abilene, Texas, 79606, United States

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Fort Worth, Texas, 76102, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78240, United States

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Vancouver, British Columbia, V5Z 3N9, Canada

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Victoria, British Columbia, V8V 4X3, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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London, Ontario, N6A 4V2, Canada

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Mississauga, Ontario, L4W 1W9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Medellín, Antioquia, Colombia

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Bogotá, Colombia

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Hyderabad, A.p., 500034, India

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Bangalore, Karnataka, 560010, India

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Kolkata, West Bengal, 700073, India

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Kfar Saba, Israel, 44281, Israel

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Petah Tikva, Israel, 49100, Israel

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Rehovot, Israel, 76100, Israel

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Tel Aviv, Israel, 64239, Israel

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MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

aflibercept; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals

clinicaltrials@regeneron.com

914 847 5385

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 21, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2012
• Last Updated: May 27, 2013
• Results First Posted: May 27, 2013

Record last verified: 2013-04

Locations

CA (6); CO (2); IL (4); IN (3); US (46)