OCTA in Epivascular Glia After Dex Implant
Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT05600179
Collaborator
(none)
38
1
20.9
1.8
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
38 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Changes in Epivascular Glia Before and After Intravitreal Dexamethasone Implant : an OCT Pilot Study
Actual Study Start Date
:
Jan 1, 2021
Actual Primary Completion Date
:
Sep 30, 2022
Actual Study Completion Date
:
Sep 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients with diabetic macular edema
|
Drug: Dexamethasone intravitreal implant
Dexamethasone intravitreal implant
|
| healthy patients
|
Outcome Measures
Primary Outcome Measures
- Changes in epivascular glia after Dexamethasone implant in patients with diabetic retinopathy and inflammatory macular edema [up to 6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- diabetic retinopathy complicated by macular edema
Exclusion Criteria:
-
congenital eye disorders,
-
previous diagnosis of other ocular diseases
-
history of vitreous hemorrhage
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Naples "Federico II" | Naples | Italy | 80100 |
Sponsors and Collaborators
- Federico II University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilda Cennamo,
professor,
Federico II University
ClinicalTrials.gov Identifier:
NCT05600179
Other Study ID Numbers:
- 0110/2022
First Posted:
Oct 31, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: