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

Completed

• Conditions: Coats Disease

• Registration Number: NCT04310631
• Lead Sponsor: Federico II University

Brief Summary

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

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab	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 (%)

Trial Locations

Locations (1)

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