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Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients (CICASAND)

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Enrolling

Conditions

Aniridia

Treatments

Procedure: Conjunctival impression
Procedure: Peripheral venous blood sample

Study type

Observational

Funder types

NETWORK

Identifiers

NCT05400590
DGT_2022_2
2022-A00259-34 (Other Identifier)

Details and patient eligibility

About

Keratopathy of patients with aniridia leads to epithelial scarring disorders and a progressive clouding of the cornea linked to this abnormal healing (fibrosis). Treatment with autologous serum is usually undertaken to promote epithelial healing.

However, autologous serum does not prevent the formation of fibrosis, whereas growth factor-rich plasma appears to be associated with a reduction in the in vitro expression of fibrosis markers. This study seeks to compare the in vitro healing and anti-fibrotic properties of autologous serum and growth factor rich plasma from aniridia patients and healthy controls.

Full description

Blood collection from aniridia patients and healthy controls, half of which will be used to make autologous serum and the other half to make growth factor rich plasma, used for in vitro studies.

A conjunctival impression will also be taken at the inclusion of the patients.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For patients with aniridia:

  • With aniridia
  • Patient weighing more than 43 kg
  • If the patient is being treated with autologous serum, a delay of 8 weeks after the last blood collection
  • If a blood donation has been made, a delay of 8 weeks must be respected after the last donation

For controls:

  • Non-aniridia (no clinical signs)
  • Weighing more than 43 kg
  • Matched to a case for sex and age +/-10 years
  • No known diabetes
  • If a blood donation has been made, a delay of 8 weeks must be respected after the latter

Exclusion criteria

  • Insufficient sample volume
  • No conjunctival print
  • HBV, HCV, HIV serology positive
  • Aniridia not genetically confirmed for cases For each patient excluded, a new patient will be included in order to maintain the number of patients required for data analysis.

Trial design

24 participants in 2 patient groups

Case patients with aniridia
Treatment:
Procedure: Peripheral venous blood sample
Procedure: Conjunctival impression
Control patients without aniridia
Treatment:
Procedure: Peripheral venous blood sample
Procedure: Conjunctival impression

Trial contacts and locations

1

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Central trial contact

Amélie YAVCHITZ

Data sourced from clinicaltrials.gov

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