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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
This study is ongoing, but not recruiting participants.
Sponsored by: Regeneron Pharmaceuticals
Information provided by: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00383370
  Purpose

To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.


Condition Intervention Phase
Neovascular Age Related Macular Degeneration
Drug: VEGF Trap
Phase I

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
Drug Information available for: Aflibercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 12
Study Start Date: October 2006
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.

  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 ≥ 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383370

Locations
United States, Florida
Fort Myers, Florida, United States
United States, New York
Lynbrook, New York, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Avner Ingerman, MD
  More Information

Study ID Numbers: VGFT-OD-0603
Study First Received: October 2, 2006
Last Updated: July 25, 2007
ClinicalTrials.gov Identifier: NCT00383370  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 14, 2009