- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00383370
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
April 20, 2011 updated by: Regeneron Pharmaceuticals
A Trial to Assess the Safety and Tolerability of Repeated Doses of Intravitreal Administration of Two VEGF Trap Formulations in Subjects With Neovascular Age Related Macular Degeneration
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses.
Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Fort Myers, Florida, United States, 33907
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Kansas
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Wichita, Kansas, United States, 67214
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Maryland
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Hagerstown, Maryland, United States, 21740
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South Carolina
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Columbia, South Carolina, United States, 29169
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Texas
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Austin, Texas, United States, 78705
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McAllen, Texas, United States, 78503
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subfoveal CNV secondary to AMD.
- Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
- ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)
Exclusion Criteria:
No 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 (Visit 2);
- PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
- Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
- Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
- Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
- Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
- History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
- Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
- Significant subfoveal atrophy or scarring.
- Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ITV-1
VEGF Trap formulation 1
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VEGF Trap formulation 1, ITV-1
Other Names:
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Experimental: ITV-2
VEGF Trap formulation 2
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VEGF Trap formulation 1, ITV-1
Other Names:
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Experimental: ITV-2 OL
VEGF Trap formulation 2 open label, higher concentration
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VEGF Trap formulation 2 at higher concentration in Open label cohort
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs.
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Avner Ingerman, MD, Regeneron Pharmaceutical
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
October 2, 2006
First Submitted That Met QC Criteria
October 2, 2006
First Posted (Estimate)
October 3, 2006
Study Record Updates
Last Update Posted (Estimate)
April 21, 2011
Last Update Submitted That Met QC Criteria
April 20, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGFT-OD-0603
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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