Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
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
1 other identifier
interventional
159
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 28, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
March 1, 2012
CompletedMarch 1, 2012
January 1, 2012
2.2 years
April 28, 2006
December 16, 2011
January 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change of CR/LT From Baseline at Week 12
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
Baseline and at Week 12
Secondary Outcomes (3)
Mean Percent Change of CR/LT From Baseline at Week 12
Baseline and at Week 12
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12
Baseline and at week 12
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12
At Week 12
Study Arms (5)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
EXPERIMENTALaflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
EXPERIMENTALaflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
EXPERIMENTALaflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
EXPERIMENTALaflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12
EXPERIMENTALInterventions
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Bayercollaborator
Study Sites (18)
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
Retina Centers, PC
Tucson, Arizona, 85704, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Loma Linda University Health Care
Loma Linda, California, 92354, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
University of Chicago
Chicago, Illinois, 60637, United States
Midwest Eye Institute
Indianapolis, Indiana, 46280, United States
Johns Hopkins Hospital School of Medicine
Baltimore, Maryland, 21287, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
New England Retina Consultants PC
West Springfield, Massachusetts, 10189, United States
Charlotte Eye, Ear, Nose & Throat Asssociates
Charlotte, North Carolina, 28210, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Retina Northwest PC
Portland, Oregon, 97210, United States
Retina Diagnostic and Treatment Assoc., LLC
Philadelphia, Pennsylvania, 19107, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Retina-Vitreous Associates, P.C.
Nashville, Tennessee, 37203, United States
Vitreoretinal Consultants Scurlock Tower Texas Medical Center
Houston, Texas, 77030, United States
Medical Center Ophthamology
San Antonio, Texas, 78240, United States
Related Publications (1)
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.
PMID: 32374423DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is a phase 2 study with small numbers of patients per group limiting the conclusions that can be drawn from the resulting data.
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2006
First Posted
May 3, 2006
Study Start
April 1, 2006
Primary Completion
June 1, 2008
Study Completion
August 1, 2008
Last Updated
March 1, 2012
Results First Posted
March 1, 2012
Record last verified: 2012-01