Skip to main content
OpenTrials
Completed

NCT Number: NCT04310631

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coats Disease Cardiovascular Diseases Eye Diseases Retinal Diseases Retinal Telangiectasis Telangiectasis Vascular Diseases

Age range

19 year–30 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab Injection

Drug

Ranibizumab Injection (0.5 mg/0.05 ml): Three monthly intravitreal injections

Primary outcomes

  1. 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)

  2. 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 (%)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.