## Protocol Section
### Identification Module
**NCT ID:** NCT05600179

**Brief Title:** OCTA in Epivascular Glia After Dex Implant

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

#### Organization Study ID Info
**ID:** 0110/2022
#### Organization
**Class:** OTHER
**Full Name:** Federico II University
### Status Module
#### Completion Date
**Date:** 2022-09-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-12-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-01

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2022-10-31
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-26
**Study First Submit QC Date:** 2022-10-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Federico II University

#### Responsible Party

**Investigator Affiliation:** Federico II University

**Investigator Full Name:** Gilda Cennamo

**Investigator Title:** professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Diabetic Retinopathy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Dexamethasone intravitreal implant

**Label:** patients with diabetic macular edema

#### Arm Group 2

**Label:** healthy patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- patients with diabetic macular edema

**Description:** Dexamethasone intravitreal implant

**Name:** Dexamethasone intravitreal implant

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Changes in epivascular glia after Dexamethasone implant in patients with diabetic retinopathy and inflammatory macular edema

**Time Frame:** up to 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* diabetic retinopathy complicated by macular edema

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Naples

**Country:** Italy

**Facility:** University of Naples "Federico II"

**Zip:** 80100

### IPD Sharing Statement Module

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000003925

- Term: Diabetic Angiopathies

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M7125

- Name: Diabetic Retinopathy

- Relevance: HIGH

- As Found: Diabetic Retinopathy

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003930

- Term: Diabetic Retinopathy

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

### Misc Info Module

- Version Holder: 2024-05-24
