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RecruitingNCT05400590CICASANDUpdated Dec 8, 2025

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

An observational study in Aniridia, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Aniridia

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Keywords

  • Growth factor rich plasma
  • Conjunctival impression
03

In context

Aniridia

23 studies on the registry are indexed under Aniridia; 8 are open to participants now.

This study's planned enrollment of 24 is below the median of 100 across 13 observational studies indexed under Aniridia.

Browse Aniridia studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 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
Yes
Sampling method
Non-probability sample

Study population

Aniridia patients and controls without aniridia

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • Case patients with aniridia

    Procedure: Peripheral venous blood sample · Procedure: Conjunctival impression

  • Control patients without aniridia

    Procedure: Peripheral venous blood sample · Procedure: Conjunctival impression

Interventions

  • ProcedurePeripheral venous blood sample

    2.5% of body weight

  • ProcedureConjunctival 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.

06

What researchers measure

Primary outcomes

  1. In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients

    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

    Time frame: Sampling done at baseline

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05400590
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Jun 1, 2022
Start date
May 15, 2023
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Dec 8, 2025

Study contacts

Amélie YAVCHITZ
Contact
ayavchitz@for.paris
(0)1 48 03 64 54 ext. +33
Eric GABISON
study chair · Hôpital Fondation A. de Rothschild
Damien GUINDOLET
principal investigator · Hôpital Fondation A. de Rothschild

Oversight

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

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