OCTA and Polypoidal Choroidal Vasculopathy

January 14, 2021 updated by: Gilda Cennamo, Federico II University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 60 years with diagnosis of polypoidal choroidal vasculopathy They did not present other ophthalmological diseases.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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