NCT05600179

Completed

OCTA in Epivascular Glia After Dex Implant

Federico II University Source

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Other study identifiers

Sponsor study identifier

0110/2022

Study Type

observational

Actual enrollment (reported)

38

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2021

Actual (reported)

Primary Completion

September 30, 2022

Actual (reported)

Study Completion

September 30, 2022

Actual (reported)

Brief 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 38 participants
Study completion date: September 30, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2021
Actual (reported)
Primary Completion
September 30, 2022
Actual (reported)
Study Completion
September 30, 2022
Actual (reported)
First Submitted
October 26, 2022
Actual (reported)
First Posted
October 31, 2022
Actual (reported)

Last Updated: December 8, 2022
Status Verified: December 2022
Last Update Submitted: December 6, 2022

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

patients with diabetic macular edema

Drug: Dexamethasone intravitreal implant

healthy patients

Interventions

Dexamethasone intravitreal implantDrug

Dexamethasone intravitreal implant

patients with diabetic macular edema

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

diabetic retinopathy complicated by macular edema

You may not qualify if:

Sponsors & Collaborators

Federico II University
Otherlead

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanes

Enrollment

38 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: professor

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

January 1, 2021

Actual (reported)

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Completed

NCT04594603

Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography

Unknown

NCT05902650

Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy

Unknown

NCT04503551

A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm

Phase 3Completed

NCT04702048

Evaluation of the Retina in Patients With Non-proliferative Diabetic Retinopathy After Aflibercept Injection in the Eye

Phase 4Withdrawn

NCT04624737

Intelligent Evaluation of Diabetic Retinopathy

Not ApplicableCompleted

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

Contact the study team to confirm eligibility.

Steroids

Fused-Ring Compounds

Polycyclic Compounds

Steroids, Fluorinated

Primary Completion

September 30, 2022

Actual (reported)

Study Completion

September 30, 2022

Actual (reported)

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing: Will share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05600179
Data provider: ClinicalTrials.gov
Source updated: 2022-12-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:56 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

patients with diabetic macular edema

healthy patients

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations