ClinicalTrials.gg
RecruitingNCT06408701OrganoEyeUpdated Mar 18, 2026

Modeling Ocular Developmental Diseases From 3D Cultures of Optic Vesicle Organoids Derived From hiPSCs of Patients With Ocular Malformations

An observational study in Eye Abnormalities, sponsored by University Hospital, Toulouse. Recruiting at 2 sites in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by University Hospital, Toulouse · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
6 Years and older
Sex
All
01

Study summary

Ocular morphogenesis is a complex process starting as early as the 4th week of embryonic life, involving interactions between varioustissues of different origin and conserved genes. Anomalies in ocular development , often of genetic origin, pose diagnostic and therapeutic challenges. Animal models are limited, so human-induced pluripotent stem cell (hiPSC)-derived optic vesicle containing brain organoids (OVBOs) offer a promising alternative. These pathological OVBOs, created from patients' cells with ocular malformations, allow for the study of underlying molecular mechanisms and testing of therapies.

Read the detailed description

The eye's ability to perform its visual functions depends on its three-dimensional structure. Ocular morphogenesis is a complex process that begins in humans as early as the 4th week of embryonic life, requiring coordinated interactions between various embryologically diverse tissues involving highly conserved genes (Cardozo MJ, 2023). Disruption in any of these stages of ocular development, due to genetic, toxic, or environmental factors, can result in growth or formation defects of the eye globe. Among the most frequent ocular developmental anomalies , there are micro-anophthalmia, coloboma, anterior segment dysgenesis and aniridia (Plaisancie J, 2019). Most of these anomalies are of genetic origin. The primary obstacle in understanding these diseases is the lack of easily accessible tissue for sampling, which would allow for expression analyses and the study of underlying molecular mechanisms.

In this group of pathologies, understanding the pathophysiological mechanisms and therapeutic development was until recently quite limited and relied almost exclusively on the establishment of genetically modified animal models, a procedure that is lengthy, costly, and cumbersome. Moreover, routine diagnostic use of this model is not feasible in a hospital setting. Therefore, it is necessary to develop new tools and models to advance the understanding and management of these pathologies. The use of human induced pluripotent stem cells (hiPSCs) now allows for the understanding of the complexity of early organ development through the generation of 3D cellular models. Indeed, recent studies have shown that hiPSC-derived brain organoids retain, in a specific culture environment, the intrinsic capacity to develop optic vesicles (OV) mimicking early physiological ocular development and containing various ocular tissues (Gabriel E, 2021).

The optic vesicle organoid (OVBO) model thus represents a preferred alternative to the animal model in studying pathophysiological mechanisms and their use in preclinical trials. In addition to ethical and financial considerations, the latter has numerous advantages, particularly allowing the study of defective mechanisms directly from patient cells (precision medicine). Researchers have already developed the OVBO model from control hiPSC lines and have characterized the model under "physiological" conditions.

The next step in understanding the model and proving its utility in patients relies on studying the induced phenotype in OVBO models generated from hiPSCs from patients with genetically characterized ocular malformations. These "pathological" OVBO models will allow for detailed study of the molecular and cellular bases involved in these patients. Once the relevance of the model is demonstrated in modeling developmental pathologies of the eye, researchers will attempt to show that the OVBO model constitutes a robust alternative to the murine model in preclinical trials.

02

Conditions studied

  • Eye Abnormalities

Keywords

  • Microphthalmia
  • Anophthalmia
  • Coloboma
  • Aniridia
03

In context

Eye Abnormalities

28 studies on the registry are indexed under Eye Abnormalities; 3 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 14 observational studies indexed under Eye Abnormalities.

Browse Eye Abnormalities studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

These patients will be solicited/sampled based on the genetic origin of the malformation they carry.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Affiliated with a social security scheme.
  • Patients with ocular malformations.
  • Signed obtained from the patient and/or their legal representatives.

Exclusion criteria

Exclusion Criteria:

  • Inability to understand the nature and objectives of the study and/or difficulties in communicating with the investigator.
  • Deprivation of liberty by judicial or administrative decision.
  • Any other pathological or psychological condition deemed incompatible by the investigator for the proper conduct of the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Subjects presenting with an ocular developmental anomaly

    Biological samples will be collected in the normal diagnosis and follow-up process

    Biological: Blood sampling

Interventions

  • BiologicalBlood sampling

    Blood will be taken in larger quantity

06

What researchers measure

Primary outcomes

  1. Culture of Optic Vesicles containing Brain Organoids (OVBOs) for the Study of Eye malformations

    Macroscopic Examination and Expression of Specific Tissue Markers to Identify Optic Vesicle Anomalies

    Time frame: Day 60 of Development

Secondary outcomes

  1. Molecular and Cellular Study of Genetically Characterized Ocular Malformations in Patients

    Identification of Genetic Basis for Observed Patient Pathology

    Time frame: through study completion, an average of 1 year

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2024 (actual). Primary completion is estimated for May 2034, 113 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2024
First posted
May 10, 2024
StartActual
Nov 5, 2024
Primary completionEst.
May 2, 2034
CompletionEst.
May 2, 2034
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06408701
Responsible party
Sponsor
First posted
May 10, 2024
Start date
Nov 5, 2024
Primary completion
May 2, 2034 (estimated)
Completion
May 2, 2034 (estimated)
Last update
Mar 18, 2026

Study contacts

Julie Plaisancie, MD, PhD
Contact
plaisancie.j@chu-toulouse.fr
0561779075 ext. +33
Julie Plaisancie, MD, PhD
principal investigator · University Hospital, Toulouse

Oversight

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

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