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Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

Inclusion Criteria: Subfoveal CNV secondary to AMD. Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT). Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters. Exclusion Criteria: History of any vitreous hemorrhage within 4 weeks prior to Day 1. Aphakia. Significant subfoveal atrophy or scarring. Prior treatment with the following in the study eye: Subfoveal thermal laser therapy. Submacular surgery or other surgical intervention for the treatment of AMD. Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1. Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1). Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1). Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1). Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy. Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin). Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.

Sites / Locations

  • Associated Retina Consultants
  • Retina Centers, PC
  • Retina Vitreous Associates Medical Group
  • Loma Linda University Health Care
  • Southeast Retina Center
  • University of Chicago
  • Midwest Eye Institute
  • Johns Hopkins Hospital School of Medicine
  • Ophthalmic Consultants of Boston
  • New England Retina Consultants PC
  • Charlotte Eye, Ear, Nose & Throat Asssociates
  • Dean A. McGee Eye Institute
  • Retina Northwest PC
  • Retina Diagnostic and Treatment Assoc., LLC
  • Black Hills Regional Eye Institute
  • Retina-Vitreous Associates, P.C.
  • Vitreoretinal Consultants Scurlock Tower Texas Medical Center
  • Medical Center Ophthamology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4

aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12

aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4

aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12

aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12

Arm Description

Outcomes

Primary Outcome Measures

Mean Change of CR/LT From Baseline at Week 12
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.

Secondary Outcome Measures

Mean Percent Change of CR/LT From Baseline at Week 12
CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12
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
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12
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

First Posted
April 28, 2006
Last Updated
January 27, 2012
Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00320788
Brief Title
Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
Official Title
A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD. The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
Detailed Description
This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period. After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Neovascular Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
Arm Type
Experimental
Arm Title
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
Arm Type
Experimental
Arm Title
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
Arm Type
Experimental
Arm Title
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
Arm Type
Experimental
Arm Title
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Other Intervention Name(s)
VEGF Trap-Eye, BAY86-5321
Intervention Description
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
Intervention Type
Biological
Intervention Name(s)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Other Intervention Name(s)
VEGF Trap-Eye, BAY86-5321
Intervention Description
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Intervention Type
Biological
Intervention Name(s)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Other Intervention Name(s)
VEGF Trap-Eye, BAY86-5321
Intervention Description
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
Intervention Type
Biological
Intervention Name(s)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Other Intervention Name(s)
VEGF Trap-Eye, BAY86-5321
Intervention Description
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Intervention Type
Biological
Intervention Name(s)
aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Other Intervention Name(s)
VEGF Trap-Eye, BAY86-5321
Intervention Description
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Primary Outcome Measure Information:
Title
Mean Change of CR/LT From Baseline at Week 12
Description
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
Time Frame
Baseline and at Week 12
Secondary Outcome Measure Information:
Title
Mean Percent Change of CR/LT From Baseline at Week 12
Description
CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
Time Frame
Baseline and at Week 12
Title
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12
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 and at week 12
Title
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12
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
At Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subfoveal CNV secondary to AMD. Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT). Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters. Exclusion Criteria: History of any vitreous hemorrhage within 4 weeks prior to Day 1. Aphakia. Significant subfoveal atrophy or scarring. Prior treatment with the following in the study eye: Subfoveal thermal laser therapy. Submacular surgery or other surgical intervention for the treatment of AMD. Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1. Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1). Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1). Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1). Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy. Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin). Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina Centers, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Loma Linda University Health Care
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Johns Hopkins Hospital School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New England Retina Consultants PC
City
West Springfield
State/Province
Massachusetts
ZIP/Postal Code
10189
Country
United States
Facility Name
Charlotte Eye, Ear, Nose & Throat Asssociates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Retina Northwest PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Retina Diagnostic and Treatment Assoc., LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Retina-Vitreous Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vitreoretinal Consultants Scurlock Tower Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical Center Ophthamology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32374423
Citation
Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21640257
Description
Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration.
URL
http://www.ncbi.nlm.nih.gov/pubmed/21640258
Description
The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing.

Learn more about this trial

Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

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