OCTA and Polypoidal Choroidal Vasculopathy

Completed

• Conditions: Polypoidal Choroidal Vasculopathy
• Interventions: Drug: Ranibizumab Injection

• Registration Number: NCT04714242
• Lead Sponsor: Federico II University

Brief Summary

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

• Study Start: 2019-01-15
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-20
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients underwent anti-VEGF therapy	Ranibizumab Injection	intravitreal Anti-VEGF therapy: Three monthly intravitreal injections

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy