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

Sponsor

Centre Georges Francois Leclerc (Other)

Overall Status

Recruiting

CT.gov ID

NCT04952688

Collaborator

(none)

Enrollment

Locations

Arm

30.9

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Other: OCT- Angiographie	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 14, 2020

Anticipated Primary Completion Date :

Jul 14, 2022

Anticipated Study Completion Date :

Jul 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Inclusion Before Anti-VEGF treatment: opht	Other: OCT- Angiographie Ophthalmological examinations

Arm

Intervention/Treatment

Experimental: Experimental

Inclusion Before Anti-VEGF treatment: opht

Other: OCT- Angiographie

Ophthalmological examinations

Outcome Measures

Primary Outcome Measures

retinal vascular density retinal vascular density [12 month]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient over 18 years old starting first-line treatment for metastatic colorectal cancer including BEVACIZUMAB (AVASTIN®)
Systemic or intraocular anti-VEGF treatment naïve
ECOG ≤ 2

Exclusion Criteria:

Pregnant woman,
Minor patient or under legal protection
Person deprived of liberty or under guardianship
Inability to undergo medical monitoring of the trial
Impossibility of carrying out the OCT-A
Patient with a contraindication to Tropicamide 0.5% eye drops
Patient with a history of degenerative macular pathology, vascular macular pathology or presenting an epiretinal membrane with traction phenomenon.
Diabetes
Patient for whom it is not possible to schedule an ophthalmology consultation before the start of treatment.