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RecruitingNCT04952688VOCANGIOUpdated Feb 13, 2024

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

An interventional study of OCT- Angiographie in Colorectal Cancer, sponsored by Centre Georges Francois Leclerc. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Centre Georges Francois Leclerc · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Dec 2020, registered Jun 2021).
  • Started Dec 2020; still recruiting 5 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • retina
  • OCT-angiography
  • Anti-VEGF
  • microvascularization
  • Targeted therapy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 30 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Centre Georges Francois Leclerc is the lead sponsor of 75 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental

    Inclusion Before Anti-VEGF treatment: opht

    Other: OCT- Angiographie

Interventions

  • OtherOCT- Angiographie

    Ophthalmological examinations

06

What researchers measure

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

    Time frame: 12 month

07

Study locations

1 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04952688
Lead sponsor
Centre Georges Francois Leclerc
Responsible party
Sponsor
First posted
Jul 7, 2021
Start date
Dec 14, 2020
Primary completion
Dec 14, 2025 (estimated)
Completion
Dec 14, 2025 (estimated)
Last update
Feb 13, 2024

Study contacts

Audrey HENNEQUIN
Contact
ahennequin@cgfl.fr
03 80 73 75 06
Audrey HENNEQUIN
principal investigator · Centre Georges François Leclerc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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