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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Macular Degeneration	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	159 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	April 2006
Actual Primary Completion Date :	June 2008
Actual Study Completion Date :	August 2008

Arms and Interventions

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Arm	Intervention/treatment
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: VEGF Trap-Eye; BAY86-5321
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: VEGF Trap-Eye; BAY86-5321
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: VEGF Trap-Eye; BAY86-5321
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: VEGF Trap-Eye; BAY86-5321
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: VEGF Trap-Eye; BAY86-5321

Outcome Measures

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Primary Outcome Measures :

1. Mean Change of CR/LT From Baseline at Week 12 [ Time Frame: Baseline and at Week 12 ]
   CR/LT measured in micrometers (µm); lower individual values represent better outcomes.

Secondary Outcome Measures :

1. Mean Percent Change of CR/LT From Baseline at Week 12 [ Time Frame: Baseline and at Week 12 ]
   CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
2. 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 ]
   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
3. 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 ]
   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

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration. 

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. 

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00320788 History of Changes
Other Study ID Numbers:	VGFT-OD-0508
First Posted:	May 3, 2006
Results First Posted:	March 1, 2012
Last Update Posted:	March 1, 2012
Last Verified:	January 2012

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