Evaluation of Retinal and Vascular Features in Coats Disease After Intravitreal Injections of Ranibizumab

March 13, 2020 updated by: Gilda Cennamo, Federico II University

Optical Coherence Tomography Angiography Findings After Intravitreal Ranibizumab in Patients With Coats Disease

This study evaluates the retinal and vascular features in patients affected by Coats disease under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography

Study Overview

Status

Completed

Conditions

Coats Disease

Intervention / Treatment

Drug: Ranibizumab Injection

Detailed Description

Coats disease is an idiopathic retinal vascular disorder, occurs in young males, and is characterized by retinal telangiactasias, numerous yellowish exudates in the subretinal space, macular edema, hemorrhages and, in advanced end-stage, by exudative retinal detachment.

Ranibizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Ranibizumab in Coats disease.

Study Type

Observational

Enrollment (Actual)

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

15 years to 26 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 18 years with diagnosis of Coats disease. They did not present other ophthalmological diseases.

Description

Inclusion Criteria:

age older than 18 years
diagnosis of Coats disease
treatment-naïve with Ranibizumab
absence of other vitreoretinal and vascular retinal diseases
absence of diabetes

Exclusion Criteria:

age younger than 18 years
No diagnosis of Coats disease
previous treatments with Ranibizumab
presence of vitreoretinal and vascular retinal diseases
presence of diabetes

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

Observational Models: Cohort
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab Time Frame: Three months	The effectiveness of Ranibizumab injections for treating Coats disease using optical coherence tomography (OCT). The parameters analyzed by OCT were: Central Macular Thickness (micron), Subfoveal Choroidal Thickness (micron)	Three months
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab Time Frame: Three months	The effectiveness of Ranibizumab injections for treating Coats disease using optical coherence tomography angiography (OCTA) The parameters analyzed by OCTA were: retinal vessel density (%), choriocapillaris vessel density (%)	Three months

Collaborators and Investigators

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

Sponsor

Federico II University

Investigators

Study Director: Daniela Montorio, 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 1, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)