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NCT05600179 Clinical Trial

OCTA in Epivascular Glia After Dex Implant

Diabetic Retinopathy Clinical Trial

Official title:
Evaluation of Changes in Epivascular Glia Before and After Intravitreal Dexamethasone Implant : an OCT Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05600179
Other study ID # 0110/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date September 30, 2022

Study information
Verified date December 2022
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this prospective study was for the first time, to analyze specific morphologic features in diabetic eyes with macular oedema, such as changes of the foveal avascular zone and the presence of epivascular glia, and see how they would change after dexamethasone intravitreal implant

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - diabetic retinopathy complicated by macular edema Exclusion Criteria: - congenital eye disorders, - previous diagnosis of other ocular diseases - history of vitreous hemorrhage

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone intravitreal implant
Dexamethasone intravitreal implant

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 Changes in epivascular glia after Dexamethasone implant in patients with diabetic retinopathy and inflammatory macular edema up to 6 months
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