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

Recruiting

• Conditions: Aniridia
• Interventions: Procedure: Peripheral venous blood sample; Procedure: Conjunctival impression

• Registration Number: NCT05400590
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-01
• Study Start: 2023-05-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control patients without aniridia	Conjunctival impression	-
Case patients with aniridia	Conjunctival impression	-
Control patients without aniridia	Peripheral venous blood sample	-
Case patients with aniridia	Peripheral venous blood sample	-

Primary Outcome Measures

Name	Time	Method
In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients	Sampling done at baseline	The corneal cell healing properties are evaluated by the time to reach confluence (number of hours) of epithelial cells, using a standardized wound healing assay (Incucyte, Essenbioscience). The corneal cell healing properties will be comparated between autologous serum, and plasma enriched with growth factors from blood of aniridia patients

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschild; 🇫🇷 Paris, France