Modifications in Retinal Microvascularization With Targeted Anti-angiogenic Therapy in Colorectal Cancer

Colorectal Cancer Clinical Trial

— VOCANGIO  

Official title:

Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952688
• Other study ID #: 2020-A01178-31
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: December 14, 2025

Study information

• Verified date: February 2024
• Source: Centre Georges Francois Leclerc
• Contact: Audrey HENNEQUIN
• Phone: 03 80 73 75 06
• Email: ahennequin[@]cgfl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Retinal microvascularization can provide important informations to systemic vascular phenomena. The non-invasive quantitative description of the retinal vascularization is now possible by performing OCT-angiography and their image analysis software (vascular density and retinal perfusion). Systemic microvacular changes during the establishment of oncological treatment by targeted antiangiogenic therapy are little described in the literature. The objective of this pilot study is to describe the evolution of the retinal vascular density of patients with antiangiogenic drugs. In addition, the evolution of the retinal vascular density of patients on antiangiogenic drugs will study as a function of the response to the treatment and the toxicity of these treatments.

Description:

The main objective of this study is to describe the change in retinal vascular density of patients with first-line colorectal cancer treated with Bevacizumab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 14, 2025
• Est. primary completion date: December 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient over 18 years old starting first-line treatment for metastatic colorectal cancer including BEVACIZUMAB (AVASTIN®)

2. Systemic or intraocular anti-VEGF treatment naïve

3. ECOG = 2

Exclusion Criteria:

1. Pregnant woman,

2. Minor patient or under legal protection

3. Person deprived of liberty or under guardianship

4. Inability to undergo medical monitoring of the trial

5. Impossibility of carrying out the OCT-A

6. Patient with a contraindication to Tropicamide 0.5% eye drops

7. Patient with a history of degenerative macular pathology, vascular macular pathology or presenting an epiretinal membrane with traction phenomenon.

8. Diabetes

9. Patient for whom it is not possible to schedule an ophthalmology consultation before the start of treatment.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• OCT- Angiographie
Ophthalmological examinations

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retinal vascular density retinal vascular density	this measurement will be the average of the 4 quadrants (temporal, nasal, superior and inferior 24). It will be performed by PLEX Elite 9000 Swept Source OCT-A before, during and at the end of the anti-angiogenic treatment	12 month