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OpenTrials
Completed

NCT Number: NCT04714242

OCTA and Polypoidal Choroidal Vasculopathy

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

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Key information

Conditions

Polypoidal Choroidal Vasculopathy Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ranibizumab Injection

Drug

Three monthly intravitreal injections of Ranibizumab

Other names: Lucentis

Primary outcomes

  1. Study of vascular features of choroid in polypoidal choroidal vasculopathy after intravitreal injections of Ranibizumab

    Time frame: 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 outcomes

  1. Study of structural features of choroid in polypoidal choroidal vasculopathy after intravitreal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Choroid and Choriocapillary Changes in Polypoidal Choroidal Vasculopathy After Intravitreal Anti-VEGF Therapy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2021
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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