AniridiaCICASANDNCT05400590
Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
An observational study of Aniridia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aniridia
- What is being tested?
- Peripheral venous blood sample and Conjunctival impression
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2023to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aniridia patients and controls without aniridia
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation A. de Rothschild
Paris, 75019
Damien GUINDOLET, dguindolet@for.paris
Eric GABISON, egabison@for.paris
About this study
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.
- Conditions
- Aniridia
- Being tested
- Peripheral venous blood sample, Conjunctival impression
- Keywords
- Growth factor rich plasma, Conjunctival impression
- Medical subject headings
- Aniridia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral venous blood sampleProcedure or surgery
2.5% of body weight
Conjunctival impressionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Case patients with aniridia | Not described Receives: Procedure: Peripheral venous blood sample; Procedure: Conjunctival impression | |
| Control patients without aniridia | Not described Receives: Procedure: Peripheral venous blood sample; Procedure: Conjunctival impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Sampling done at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start15 May 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AniridiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Eric GABISON, Study chair, Hôpital Fondation A. de RothschildDamien GUINDOLET, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400590
- Sponsor's protocol ID
- DGT_2022_2
- Other IDs
- 2022-A00259-34
- Acronym
- CICASAND
- Status last verified
- Dec 2025
- First submitted
- 23 May 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
- ClinicalTrials.gov ID
- NCT05400590
- Acronym / sponsor ID
- CICASAND / DGT_2022_2
- Conditions
- Aniridia
- Keywords
- Growth factor rich plasma, Conjunctival impression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 May 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case patients with aniridia | – | Procedure: Peripheral venous blood sample, Procedure: Conjunctival impression |
| Control patients without aniridia | – | Procedure: Peripheral venous blood sample, Procedure: Conjunctival impression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aniridia patients and controls without aniridia
Key inclusion criteria (11 listed)
- 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
- Non-aniridia (no clinical signs)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral venous blood sample2.5% of body weight | Procedure or surgery | Case patients with aniridia, Control patients without aniridia |
| Conjunctival impressionCollection 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. | Procedure or surgery | Case patients with aniridia, Control patients without aniridia |
Primary outcome
In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric GABISON study chair
Hôpital Fondation A. de Rothschild
Damien GUINDOLET principal investigator
Hôpital Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aniridia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie YAVCHITZ ((0)1 48 03 64 54 ext. +33, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vitro comparison of the corneal cell healing properties of autologous serum and plasma enriched with growth factors from blood of aniridia patients (time frame: Sampling done at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.