BridgeMD
New treatment option for Rare Diseases
Official title Identification of Cellular Biomarkers of Rare Eye Diseases in Adults
ClinicalTrials.gov ID: NCT07063719
What this study is testing
- What it's testing
- The cornea is the outermost transparent 'window' of the eye allowing light to enter and serving as the first-line immune and mechanical barrier. It is a complex avascular tissue composed of cells, stem cells, nerves, and collagen layers organized in an exquisite manner to maintain its transparency and self-healing capacity.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patient group:
- Women and men with age equal or higher than 18 years (patients planning to conceive may be included in the study)
- Willingness and ability to read and understand the informed consent.
- Diagnosis (including genotype, if needed) of REDs.
- Affiliation with a social security scheme or beneficiary of such a scheme. RED 1 - AAK Diagnosis criteria
You likely can't join if
- Patient group:
- Pregnancy, breastfeeding (in case any stress was caused to the woman by the biological sampling).
- Descemetocele/impending corneal perforation.
- Recent (less than 3 months) ocular surgery.
- Recent (less than 1 month) change in topical medications type and frequency of the ocular pathology.
- Persons subject to a legal protection measure (under guardianship, curatorship or safeguard of justice) Control group:
See the full eligibility criteria
- Patient group:
- Women and men with age equal or higher than 18 years (patients planning to conceive may be included in the study)
- Willingness and ability to read and understand the informed consent.
- Diagnosis (including genotype, if needed) of REDs.
- Affiliation with a social security scheme or beneficiary of such a scheme. RED 1 - AAK Diagnosis criteria
- Compatible slit lamp examination (iris/pupillary abnormalities, with or without corneal opacification, vascularization, cataract, glaucoma). with or without:
- Foveal hypoplasia and optic disc malformations as detected through fundus examination or OCT tomography
- Compatible anterior segment OCT or high-frequency ultrasound biomicroscopy (UBM)
- Positive genetic testing RED 2 - NK Diagnosis criteria
- Compatible history and slit lamp findings of one of the three stages of the Mackie classification (I - punctate keratopathy; II - persistent epithelial defect; III - stromal involvement)
- Reduced/absent corneal sensitivity
- Exclusion of infectious or toxic etiologies with or without:
- confocal microscopy findings RED 3 - LSCD Diagnosis criteria
- Compatible history and slit lamp examination (e.g. corneal conjunctivalization with persistent epithelial defects, loss of limbal anatomy or irregular staining with fluorescein) with or without:
- confocal microscopy findings RED 4 - OCP Diagnosis criteria
- Compatible slit lamp examination
- Exclusion of infectious or toxic etiologies with or without:
- conjunctival /oral biopsy with characteristic mucous pemphigoid findings RED 5 - OC GVHD Diagnosis criteria Compatible history and slit lamp examination consistent with one of 4 grades of ocular GVHD (1 - conjunctival...
- Compatible slit lamp examination
- Compatible systemic findings with or without:
- Positive genetic testing RED 7- CNV Diagnosis criteria
- Compatible slit lamp examination of corneal stromal neovascularization (1-4 quadrants)
- Exclusion of infectious or toxic etiologies with or without:
- confocal microscopy findings Control group:
- Women and men with age equal or higher than 18 years (patients planning to conceive may be included in the study).
- Willingness and ability to read and understand the informed consent.
- Non-diagnosis of REDs.
- Affiliation with a social security scheme of beneficiary of such a scheme.
- Patient group:
- Pregnancy, breastfeeding (in case any stress was caused to the woman by the biological sampling).
- Descemetocele/impending corneal perforation.
- Recent (less than 3 months) ocular surgery.
- Recent (less than 1 month) change in topical medications type and frequency of the ocular pathology.
- Persons subject to a legal protection measure (under guardianship, curatorship or safeguard of justice) Control group:
- Pregnancy, breastfeeding.
- Active ocular infection.
- Descemetocele/impending corneal perforation.
- Recent (less than 3 months) ocular surgery.
- Recent (less than 1 month) change in topical medications type and frequency of the ocular pathology.
- Persons subject to a legal protection measure. (under guardianship, curatorship or safeguard of justice)
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.