## Protocol Section
### Identification Module
**NCT ID:** NCT06416241

**Acronym:** INTRAMED-CRVO

**Brief Title:** Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

**Official Title:** Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

#### Organization Study ID Info
**ID:** 699/2019
#### Organization
**Class:** OTHER
**Full Name:** University of Athens
### Status Module
#### Completion Date
**Date:** 2024-03-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Athens

#### Responsible Party

**Investigator Affiliation:** National and Kapodistrian University of Athens

**Investigator Full Name:** Irini Chatziralli

**Investigator Title:** Associate Professor in Ophthalmology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion.

Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials.

The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.

### Conditions Module

**Conditions:**

- Retinal Vein Occlusion

- Vascular Occlusive Disease

**Keywords:**

- optical coherence tomography angiography

- aflibercept

- retinal vein occlusion

- biomarkers

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 51

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: EYLEA 2 MG in 0.05 ML Injection

**Label:** Eylea 2.0mg/0.05ml

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Eylea 2.0mg/0.05ml

**Description:** Intravitreal injection

**Name:** EYLEA 2 MG in 0.05 ML Injection

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in visual acuity as measured using ETDRS charts

**Time Frame:** 5 years

**Measure:** Change in retinal thickness as measured in μm using spectral domain optical coherence tomography

**Time Frame:** 5 years

#### Secondary Outcomes

**Measure:** Change in microvascular parameters in OCT angiography (vessel density, FAZ area)

**Time Frame:** 2 years

**Measure:** Complications

**Time Frame:** 5 years

**Measure:** Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months.
* Patients \>18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions
* BCVA of Snellen of 20/40 to 20/200 in the study eye

Exclusion Criteria:

* Previous PRP or macular laser photocoagulation in the study eye.
* Any prior ocular treatment in the study eye for macular edema secondary to CRVO.
* Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study.
* Any active or previous inflammation, ocular trauma
* Uncontrolled glaucoma (IOP\>30 mmHg)

**Healthy Volunteers:** True

**Maximum Age:** 95 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008268

- Term: Macular Degeneration

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000020246

- Term: Venous Thrombosis

- ID: D000013927

- Term: Thrombosis

- ID: D000016769

- Term: Embolism and Thrombosis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M11261

- Name: Macular Edema

- Relevance: HIGH

- As Found: Macular Edema

- ID: M7657

- Name: Edema

- Relevance: LOW

- As Found: Unknown

- ID: M15005

- Name: Retinal Vein Occlusion

- Relevance: HIGH

- As Found: Retinal Vein Occlusion

- ID: M11260

- Name: Macular Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16686

- Name: Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M22071

- Name: Venous Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M7784

- Name: Embolism

- Relevance: LOW

- As Found: Unknown

- ID: M19128

- Name: Embolism and Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008269

- Term: Macular Edema

- ID: D000012170

- Term: Retinal Vein Occlusion

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M257727

- Name: Aflibercept

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
