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

Intervention / Treatment

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)

5

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

No

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)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT1003/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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