OCTA in Epivascular Glia After Dex Implant

December 6, 2022 updated by: Gilda Cennamo, Federico II University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 18 years with diagnosis of inflammatory diabetic macular edema glaucoma..

Description

Inclusion Criteria:

  • diabetic retinopathy complicated by macular edema

Exclusion Criteria:

  • congenital eye disorders,
  • previous diagnosis of other ocular diseases
  • history of vitreous hemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with diabetic macular edema
Drug: Dexamethasone intravitreal implant
Dexamethasone intravitreal implant
healthy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in epivascular glia after Dexamethasone implant in patients with diabetic retinopathy and inflammatory macular edema
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 28, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0110/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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