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VEGF and PEDF in Patients With Myopic Choroidal Neovascularization

Sponsor
Università degli Studi di Brescia (Other)
Overall Status
Completed
CT.gov ID
NCT02175940
Collaborator
Ciro Costagliola (Other), Francesco Semeraro (Other), Roberto dell'Omo (Other), Mario R Romano (Other), Fabiana Aceto (Other), Rodolfo Mastropasqua (Other), Antonio Porcellini (Other)
40
Enrollment
1
Location
10
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effect of Intravitreal Ranibizumab Injection on Aqueous Humor Concentrations of Vascular Endothelial Growth Factor and Pigment Epithelium-derived Factor in Patients With Myopic Choroidal Neovascularization.
    Study Start Date :
    Jul 1, 2013
    Actual Primary Completion Date :
    Jan 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Myopic Choroidal Neovascularization patients
    Control patients undergoing cataract surgery

    Outcome Measures

    Primary Outcome Measures

    1. vascular endothelial growth factor (VEGF) aqueous levels [2 months]

      VEGF aqueous levels before and after intravitreal ranibizumab

    2. pigment epithelium-derived factor (PEDF) aqueous levels [2 months]

      PEDF aqueous levels before and after intravitreal ranibizumab

    Secondary Outcome Measures

    1. best-corrected visual acuity [2 months]

    2. central retinal thickness [2 months]

    Eligibility Criteria

    Criteria

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

    • pathologic myopia, defined as spherical equivalent >6 diopters and axial length >26 mm

    • posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);

    • fluorescein angiography, indocyanine green angiography and optical coherence tomography detection of the subfoveal or juxtafoveal choroidal neovascularization

    • clear ocular media;

    Exclusion Criteria:

    • previous treatment for choroidal neovascularization, including the previous intravitreal drug injection or PDT

    • presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion

    • history of recent myocardial infarction or other thromboembolic events

    • ongoing uncontrolled hypertension or glaucoma

    • refractive media opacities

    • previous eye surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Retina Department, University of Molise Cambpobasso CB Italy 86100

    Sponsors and Collaborators

    • Università degli Studi di Brescia
    • Ciro Costagliola
    • Francesco Semeraro
    • Roberto dell'Omo
    • Mario R Romano
    • Fabiana Aceto
    • Rodolfo Mastropasqua
    • Antonio Porcellini

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Russo, MD, PhD Researcher, Università degli Studi di Brescia
    ClinicalTrials.gov Identifier:
    NCT02175940
    Other Study ID Numbers:
    • VEGF001
    First Posted:
    Jun 26, 2014
    Last Update Posted:
    Jun 26, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Choroidal Neovascularization
    Myopia
    Neovascularization, Pathologic

    Study Results

    No Results Posted as of Jun 26, 2014