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Clinical Trials in France / NCT05400590
Recruiting Observational

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

NCT05400590 · tracked via the Priya Life Science France tracker
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Phase
Observational
Started
2023-05-15
Last updated
2025-12-08

Condition(s) studied

Aniridia

Investigational drug(s) / intervention(s)

Peripheral venous blood sampleConjunctival impression

Peripheral venous blood sample: 2.5% of body weight

Conjunctival impression: Collection of the most superficial conjunctival epithelial cells (desquamating) in a non- or minimally invasive, quick and almost painless way, for a biological analysis of ocular surface diseases. Application of a filter paper on the bulbar conjunctiva, under local anesthesia.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Hôpital Fondation A. de Rothschild Paris France Recruiting

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Other trials for the same condition

National Cohort on Congenital Defects of the Eye Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05400590 on ClinicalTrials.gov ↗ ← All trials in France