Trials Sponsors Conditions Drugs Pricing

Conditions

Macular Edema Secondary to Central Retinal Vein Occlusion

Keywords

Macular edemaRetinal vein occlusionCRVOVEGF Trap-Eyebest-corrected visual acuityRegeneronCOPERNICUS

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 2.0mgBiological

Monthly intravitreal injection out to the Week 24 Primary endpoint

VEGF Trap-Eye

ShamDrug

Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Sham

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Bayer
Industrycollaborator
Regeneron Pharmaceuticals
Industrylead

Study Sites (61)

Phoenix, Arizona, 85014, United States

Phoenix, Arizona, 85020, United States

Tucson, Arizona, 85704, United States

Arcadia, California, 91007, United States

Beverly Hills, California, 90211, United States

La Jolla, California, 92037, United States

Mountain View, California, 94040, United States

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

afliberceptsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title: Clinical Trials Administrator
Organization: Regeneron Pharmaceuticals

Study Officials

Clinical Trial Management
Regeneron Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

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

Enrollment

189 participants (actual enrollment reported by the registry).

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 2009

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

VEGF Trap-Eye

Sham

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (61)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

VEGF Trap-Eye

Sham

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (61)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations