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

February 12, 2024 updated by: Centre Georges Francois Leclerc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

Inclusion

Before Anti-VEGF treatment: opht
Other: OCT- Angiographie
Ophthalmological examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Investigators

  • Principal Investigator: Audrey HENNEQUIN, Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Estimated)

December 14, 2025

Study Completion (Estimated)

December 14, 2025

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01178-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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