OCTA and Polypoidal Choroidal Vasculopathy

NCT04714242 | Completed

• 1 other identifier: 1401/21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Study of structural features of choroid in polypoidal choroidal vasculopathy after intravitreal

  12 Months

Study Arms (2)

Patients underwent anti-VEGF therapy

intravitreal Anti-VEGF therapy: Three monthly intravitreal injections

Drug: Ranibizumab Injection

Control Group

Healthy eyes without actual and previous ocular diseases

Interventions

Ranibizumab Injection DRUG

Three monthly intravitreal injections of Ranibizumab

Also known as: Lucentis

Patients underwent anti-VEGF therapy

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gilda Cennamo

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: January 15, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 20, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

IT (1)