Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
This study has been completed.
Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00320788
First received: April 28, 2006
Last updated: January 27, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
tumor necrosis factor receptor-associated periodic syndrome
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Aflibercept
U.S. FDA Resources
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- Mean Change of CR/LT From Baseline at Week 12 [ Time Frame: Baseline and at Week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and at Week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and at week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]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
| Enrollment: | 159 |
| Study Start Date: | April 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4 |
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12 |
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4 |
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12 |
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12 |
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320788
Locations
| United States, Arizona | |
| Associated Retina Consultants | |
| Phoenix, Arizona, United States, 85020 | |
| Retina Centers, PC | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Retina Vitreous Associates Medical Group | |
| Beverly Hills, California, United States, 90211 | |
| Loma Linda University Health Care | |
| Loma Linda, California, United States, 92354 | |
| United States, Georgia | |
| Southeast Retina Center | |
| Augusta, Georgia, United States, 30909 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Midwest Eye Institute | |
| Indianapolis, Indiana, United States, 46280 | |
| United States, Maryland | |
| Johns Hopkins Hospital School of Medicine | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Ophthalmic Consultants of Boston | |
| Boston, Massachusetts, United States, 02114 | |
| New England Retina Consultants PC | |
| West Springfield, Massachusetts, United States, 10189 | |
| United States, North Carolina | |
| Charlotte Eye, Ear, Nose & Throat Asssociates | |
| Charlotte, North Carolina, United States, 28210 | |
| United States, Oklahoma | |
| Dean A. McGee Eye Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Retina Northwest PC | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Retina Diagnostic and Treatment Assoc., LLC | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Dakota | |
| Black Hills Regional Eye Institute | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Retina-Vitreous Associates, P.C. | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Vitreoretinal Consultants Scurlock Tower Texas Medical Center | |
| Houston, Texas, United States, 77030 | |
| Medical Center Ophthamology | |
| San Antonio, Texas, United States, 78240 | |
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00320788 History of Changes |
| Other Study ID Numbers: | VGFT-OD-0508 |
| Study First Received: | April 28, 2006 |
| Results First Received: | December 16, 2011 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Regeneron Pharmaceuticals:
|
Neovascular Age-Related Macular Degeneration |
Additional relevant MeSH terms:
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
Endothelial Growth Factors Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013