Safety and Efficacy of Repeated Intravitreal Administration of VEGF-Trap in Patients With Wet AMD - Full Text View

Sponsor:	Regeneron Pharmaceuticals
Collaborator:	Bayer
Information provided by (Responsible Party):	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00320788

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	Drug: VEGF Trap	Phase II

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 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:

Safety, biological effect (optical coherence tomography [OCT], fluorescein angiography, visual acuity) [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics, immunogenicity, quality of life [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]

Enrollment:	159
Study Start Date:	April 2006
Study Completion Date:	June 2008
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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 ITV injections of VEGF Trap into the study eye at 4- or 12-week intervals over a 12-week period. Beginning with Week 16, all patients will be evaluated every 4 weeks for continued dosing for up to one year. The fellow eye may also be eligible for treatment with VEGF Trap beginning at this	Drug: VEGF Trap Subjects in Group A will receive 2 ITV injections of 0.5 mg VEGF Trap at 12-week intervals; Group B subjects will receive 4 ITV injections of 0.5 mg VEGF Trap at 4-week intervals; Group C subjects will receive 2 injections of 2.0 mg VEGF Trap at 12-week intervals; Group D subjects will receive 4 injections of 2.0 mg VEGF Trap at 4-week intervals, and Group E subjects will receive 2 injections of 4.0 mg VEGF Trap at 12-week intervals. Other Name: Aflibercept

Arms

Assigned Interventions

1

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 ITV injections of VEGF Trap into the study eye at 4- or 12-week intervals over a 12-week period.

Beginning with Week 16, all patients will be evaluated every 4 weeks for continued dosing for up to one year. The fellow eye may also be eligible for treatment with VEGF Trap beginning at this

Drug: VEGF Trap

Subjects in Group A will receive 2 ITV injections of 0.5 mg VEGF Trap at 12-week intervals; Group B subjects will receive 4 ITV injections of 0.5 mg VEGF Trap at 4-week intervals; Group C subjects will receive 2 injections of 2.0 mg VEGF Trap at 12-week intervals; Group D subjects will receive 4 injections of 2.0 mg VEGF Trap at 4-week intervals, and Group E subjects will receive 2 injections of 4.0 mg VEGF Trap at 12-week intervals.

Other Name: Aflibercept

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 (ITV) 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 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:

Avner Ingerman, MD

Regeneron Pharmaceuticals

More 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
Last Updated:	December 1, 2011
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

ClinicalTrials.gov processed this record on February 09, 2012