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Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

Primary Purpose

Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

VEGF Trap Eye

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring VEGF Trap-Eye, Macular Degeneration, AMD, Neovascular Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion Criteria:

Any ocular or systemic adverse events that would preclude participation
Presence of any condition that would jeopardize subject's participation

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AE)

Number of participants with AEs summarized by category

Secondary Outcome Measures

Frequency (Number of Injections)

Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).

Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values

Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.

Full Information

NCT ID

NCT00527423

First Posted

September 6, 2007

Last Updated

June 10, 2013

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00527423

Brief Title

Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

Official Title

A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Detailed Description

Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Degeneration

Keywords

VEGF Trap-Eye, Macular Degeneration, AMD, Neovascular Age-Related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

157 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VEGF Trap Eye

Other Intervention Name(s)

IVT

Intervention Description

Intravitreal injection

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AE)

Description

Number of participants with AEs summarized by category

Time Frame

Baseline of this study to Wk 152

Secondary Outcome Measure Information:

Title

Frequency (Number of Injections)

Description

Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).

Time Frame

Baseline of this study to Wk 152

Title

Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values

Description

Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.

Time Frame

Baseline of original study to Wk 156

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prior participation in VEGF Trap-Eye Phase I and II studies Exclusion Criteria: Any ocular or systemic adverse events that would preclude participation Presence of any condition that would jeopardize subject's participation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

City

Ft. Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

City

Stuart

State/Province

Florida

ZIP/Postal Code

34994

Country

United States

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

City

Glenview

State/Province

Illinois

ZIP/Postal Code

60026

Country

United States

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

47280

Country

United States

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

City

West Springfield

State/Province

Massachusetts

ZIP/Postal Code

01089

Country

United States

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

City

Lynbrook

State/Province

New York

ZIP/Postal Code

11563

Country

United States

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

City

W. Columbia

State/Province

South Carolina

ZIP/Postal Code

29169

Country

United States

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76102

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

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