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

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ClinicalTrials.gov Identifier: NCT00320788
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : March 1, 2012
Last Update Posted : March 1, 2012
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept

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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320788


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00320788    
Other Study ID Numbers: VGFT-OD-0508
First Posted: May 3, 2006    Key Record Dates
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:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases