NCT05600179

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

1.7 years

First QC Date

October 26, 2022

Last Update Submit

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

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:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

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

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Locations

IT(1)