OCTA and Polypoidal Choroidal Vasculopathy

NCT ID: NCT04714242

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polypoidal Choroidal Vasculopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients underwent anti-VEGF therapy

intravitreal Anti-VEGF therapy: Three monthly intravitreal injections

Ranibizumab Injection

Intervention Type DRUG

Three monthly intravitreal injections of Ranibizumab

Control Group

Healthy eyes without actual and previous ocular diseases

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ranibizumab Injection

Three monthly intravitreal injections of Ranibizumab

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lucentis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federico II University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gilda Cennamo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gilda Cennamo

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Naples "Federico II"

Naples, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1401/21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.