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OCTA and Polypoidal Choroidal Vasculopathy

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT04714242
Collaborator
(none)
60
Enrollment
1
Location
23.2
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the structural and vascular features of choroid in patients affected by PCV after Ranibizumab intravitreal injection.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ranibizumab Injection

Detailed Description

Polypoidal choroidal vasculopathy represents a distinct form of choroidal neovascularization.

The study investigated the changes in choroidal vascular network after anti-VEGF therapy using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Choroid and Choriocapillary Changes in Polypoidal Choroidal Vasculopathy After Intravitreal Anti-VEGF Therapy
Actual Study Start Date :
Jan 15, 2019
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Dec 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients underwent anti-VEGF therapy

intravitreal Anti-VEGF therapy: Three monthly intravitreal injections

Drug: Ranibizumab Injection
Three monthly intravitreal injections of Ranibizumab
Other Names:
  • Lucentis

    		•
    Control Group

    Healthy eyes without actual and previous ocular diseases

    Outcome Measures

    Primary Outcome Measures

    1. Study of vascular features of choroid in polypoidal choroidal vasculopathy after intravitreal injections of Ranibizumab [12 Months]

      The effectiveness of Ranibizumab injections for treating PCV using optical optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: choriocapillaris vessel density.

    Secondary Outcome Measures

    1. Study of structural features of choroid in polypoidal choroidal vasculopathy after intravitreal [12 Months]

      The effectiveness of Ranibizumab injections for treating PCV using optical optical coherence tomography. The parameters analyzed by optical coherence tomography were: subfoveal choroidal thickness.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • age older than 60 years

    • diagnosis of polypoidal choroidal vasculopathy

    • absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.

    • absence of significant lens opacities, low-quality OCT-A images.

    Exclusion Criteria:

    • age older than 80 years

    • absence of diagnosis of polypoidal choroidal vasculopathy

    • presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.

    • presence of significant lens opacities, low-quality OCT-A images.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Naples "Federico II" Naples Italy 80100

    Sponsors and Collaborators

    • Federico II University

    Investigators

    • Principal Investigator: Gilda Cennamo, Federico II University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilda Cennamo, Principal Investigator, Federico II University
    ClinicalTrials.gov Identifier:
    NCT04714242
    Other Study ID Numbers:
    • 1401/21
    First Posted:
    Jan 19, 2021
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vascular Diseases
    Ranibizumab

    Study Results

    No Results Posted as of Jan 19, 2021