Evaluation of Retinal and Vascular Features in Coats Disease After Intravitreal Injections of Ranibizumab
Optical Coherence Tomography Angiography Findings After Intravitreal Ranibizumab in Patients With Coats Disease
1 other identifier
observational
5
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedMarch 17, 2020
March 1, 2020
4 years
March 10, 2020
March 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Interventions
Ranibizumab Injection (0.5 mg/0.05 ml): Three monthly intravitreal injections
Eligibility Criteria
The participans were older than 18 years with diagnosis of Coats disease. They did not present other ophthalmological diseases.
You may qualify if:
- age older than 18 years
- diagnosis of Coats disease
- treatment-naïve with Ranibizumab
- absence of other vitreoretinal and vascular retinal diseases
- absence of diabetes
You may not qualify if:
- age younger than 18 years
- No diagnosis of Coats disease
- previous treatments with Ranibizumab
- presence of vitreoretinal and vascular retinal diseases
- presence of diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Naples "Federico II"
Naples, 80100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilda Cennamo
Federico II University
- STUDY DIRECTOR
Daniela Montorio
Federico II University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 17, 2020
Study Start
January 1, 2016
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 17, 2020
Record last verified: 2020-03