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Clinical Trials/NCT04952688
NCT04952688
Recruiting
Not Applicable

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

Centre Georges Francois Leclerc2 sites in 1 country30 target enrollmentDecember 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Centre Georges Francois Leclerc
Enrollment
30
Locations
2
Primary Endpoint
retinal vascular density retinal vascular density
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2020
End Date
December 14, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

retinal vascular density retinal vascular density

Time Frame: 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

Study Sites (2)

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