Clincosm LogoSign in Get a demo

Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00383370
Collaborator
(none)
20
Enrollment
6
Locations
3
Arms
21
Duration (Months)
3.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: VEGF Trap
  • Biological: VEGF Trap
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: ITV-1

VEGF Trap formulation 1

Drug: VEGF Trap
VEGF Trap formulation 1, ITV-1
Other Names:
  • ITV-1

    		•
    Experimental: ITV-2

    VEGF Trap formulation 2

    Drug: VEGF Trap
    VEGF Trap formulation 1, ITV-1
    Other Names:
  • ITV-1

    		•
    Experimental: ITV-2 OL

    VEGF Trap formulation 2 open label, higher concentration

    Biological: VEGF Trap
    VEGF Trap formulation 2 at higher concentration in Open label cohort
    Other Names:
  • ITV-2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Fort Myers Florida United States 33907
    2 Wichita Kansas United States 67214
    3 Hagerstown Maryland United States 21740
    4 Columbia South Carolina United States 29169
    5 Austin Texas United States 78705
    6 McAllen Texas United States 78503

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Avner Ingerman, MD, Regeneron Pharmaceutical

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00383370
    Other Study ID Numbers:
    • VGFT-OD-0603
    First Posted:
    Oct 3, 2006
    Last Update Posted:
    Apr 21, 2011
    Last Verified:
    Apr 1, 2011
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration
    Aflibercept

    Study Results

    No Results Posted as of Apr 21, 2011