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

NCT ID: NCT04310631

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Coats Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Ranibizumab Injection

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gilda Cennamo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilda Cennamo

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Daniela Montorio

Role: STUDY_DIRECTOR

Federico II University

Locations

University of Naples "Federico II"

Naples, , Italy

Countries

Italy

Other Identifiers

PT1003/20

Identifier Type: -

Identifier Source: org_study_id