OCTA and Polypoidal Choroidal Vasculopathy

Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714242
• Other study ID #: 1401/21
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: January 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 20, 2020
• Est. primary completion date: December 15, 2020
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• Ranibizumab Injection
Three monthly intravitreal injections of Ranibizumab

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of vascular features of choroid in polypoidal choroidal vasculopathy after intravitreal injections of Ranibizumab	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	Study of structural features of choroid in polypoidal choroidal vasculopathy after intravitreal	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