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

NCT04952688 | Recruiting

• 1 other identifier: 2020-A01178-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Keywords

retina; OCT-angiography; Anti-VEGF; microvascularization; Targeted therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

Inclusion Before Anti-VEGF treatment: opht

Other: OCT- Angiographie

Interventions

OCT- Angiographie OTHER

Ophthalmological examinations

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (2)

Centre Georges François Leclerc

Dijon, 21000, France

RECRUITING

CHU de Dijon

Dijon, 21000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Audrey HENNEQUIN

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey HENNEQUIN

CONTACT

03 80 73 75 06; ahennequin@cgfl.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 7, 2021
• Study Start: December 14, 2020
• Primary Completion: December 14, 2025
• Study Completion: December 14, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

FR (2)