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Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)

Sponsor
GenVec (Industry)
Overall Status
Completed
CT.gov ID
NCT00109499
Collaborator
(none)
9
Locations

Study Details

Study Description

Brief Summary

The primary purpose of this study is to assess the safety of AdGVPEDF.11D when given to patients with "wet" age-related macular degeneration (AMD). AdGVPEDF.11D is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for the PEDF (pigment epithelium-derived factor) protein. PEDF is a protein that naturally exists in the human eye, but whose levels are altered in diseases characterized by ocular neovascularization like AMD. The PEDF protein is known to have anti-angiogenic effects or, in other words, it has the ability to inhibit growth of new blood vessels.

AdGVPEDF.11D will be delivered once via intravitreal injection into one eye. The injected eye will be the eye with the worst visual acuity.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Phase I, Single Administration, Dose- Escalation Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    • Age greater than or equal to 50 years;

    • Severe neovascular AMD in at least one eye responsible for a best corrected vision of 20/200 or worse in the study eye (if both eyes have neovascular AMD and equal visual acuity scores, the study eye will be determined by the investigator);

    • Best corrected visual acuity in the fellow eye must be equal to or better than the study eye;

    • Fluorescein angiography of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion. The subfoveal component must consist of CNV (choroidal neovascularization), blood or fibrosis. The total size of the lesion must be ≤12 MPS disc areas. The presence of a leaking subfoveal choroidal neovascular lesion will be evaluated by the investigator at the clinical site to determine patients' eligibility.

    • Must not be candidates for (including patients who have had treatment with either modality in the past and are no longer candidates) or must have refused treatment with subfoveal laser photocoagulation or PDT (photodynamic therapy);

    • Informed consent;

    • Able to comply with protocol requirements including follow-up visits.

    Exclusion Criteria:

    • Liver enzymes > 2 x ULN (ALT, AST, bilirubin);

    • Clinical evidence of active infection of any type, including adenovirus, hepatitis A, B, or C virus or HIV virus;

    • Other treatment for AMD in the study eye within the last twelve weeks prior to Day 1;

    • Other experimental medications within the last four weeks prior to Day 1;

    • Significant retinal disease other than neovascular AMD, such as diabetic retinopathy or retinal vascular occlusion;

    • Significant non-retinal disease such as ocular atrophy;

    • Cataract or other significant media opacity that might compromise examination and photography of the posterior segment;

    • Other causes of choroidal neovascularization such as pathologic myopia ( > 8 diopters), ocular histoplasmosis or angioid streaks;

    • Evidence of inflammation (grade 1 or higher) in the anterior and/or posterior chambers;

    • Cataract surgery or submacular surgery within 3 months;

    • Prior ocular treatment with radiation;

    • Known allergy to fluorescein;

    • Abnormal prothrombin or partial thromboplastin time ( > 1.5 X ULN) or anticoagulant therapy that cannot be withheld for treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retina-Vitreous Associates Medical Group Beverly Hills California United States 90211
    2 Retinal Transplantation Laboratory Los Angeles California United States 90033-4682
    3 UCLA - Jules Stein Eye Research Center Los Angeles California United States 90095-7000
    4 Florida Eye Microsurgical Institute, Inc. Boynton Beach Florida United States 33426
    5 Johns Hopkins Hospital School of Medicine Baltimore Maryland United States 21287
    6 Kresge Eye Institute Detroit Michigan United States 48201-1423
    7 Casey Eye Institute Portland Oregon United States 97201
    8 Baylor College of Medicine Houston Texas United States 77030
    9 University of Washington Seattle Washington United States 98195

    Sponsors and Collaborators

    • GenVec

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00109499
    Other Study ID Numbers:
    • GV-003.001
    First Posted:
    Apr 29, 2005
    Last Update Posted:
    May 12, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    Wet Age-Related Macular Degeneration
    Age-Related Maculopathies
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of May 12, 2011