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

Coats Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310631
• Other study ID #: PT1003/20
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Coats Disease
• Retinal Telangiectasis

Intervention

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

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab	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
Primary	Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab	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