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New treatment option for Pseudoxanthoma Elasticum
Official title CHOPXE - Analysis of Choriocapillaris Flow Deficits in Patients With Pseudoxanthoma Elasticum
ClinicalTrials.gov ID: NCT07006649
What this study is testing
- What it's testing
- This observational study sets out to compare choriocapillaris flow deficits between healthy control subjects and patients with pseudoxanthoma elasticum. Pseudoxanthoma elasticum (PXE) is a rare, incurable hereditary disease caused by genetic mutations.
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
- Participant not afflicted by the disease under investigation and without ophthalmological pathology
- Person matched in age (+/- 5 years) and gender to a case (patient with PXE in pre-atrophic stages included in the PXE cohort)
- Signature of informed consent for participation in the protocol
- Adult at time of for non-inclusion of research people
- Known ophthalmological diseases (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the aetiology)
You likely can't join if
- Ophthalmic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy, whatever the etiology) discovered during the ophthalmic workup
- AngioOCT examination inexploitable (artifact and/or image quality less than 50/100 even after pupillary dilation)
- Severe myopia (sphere \> - 6 dioptres) discovered during the ophthalmic workup. Case inclusion critera :
- Patient diagnosed with pseudoxanthoma elasticum, defined according to Plomp's criteria: two out of three features related to PXE: (1) two pathogenic...
- Included in the PXE cohort ;
- With pre-atrophic damage, i.e. at least one eye without choroidal neovessels on OCT-A, without previous intravitreal injection of anti-VEGF, and...
See the full eligibility criteria
- Participant not afflicted by the disease under investigation and without ophthalmological pathology
- Person matched in age (+/- 5 years) and gender to a case (patient with PXE in pre-atrophic stages included in the PXE cohort)
- Signature of informed consent for participation in the protocol
- Adult at time of for non-inclusion of research people
- Known ophthalmological diseases (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the aetiology)
- Known severe myopia, defined by a sphere \> - 6 dioptres
- Diabetic subject
- Unable to carry out the ophthalmological examinations of the study
- Pregnant, breast-feeding or parturient woman
- Person undergoing psychiatric care under constraint
- Person subject to a legal protection measure
- Person not affiliated or not benefiting from a social security scheme
- Ophthalmic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy, whatever the etiology) discovered during the ophthalmic workup
- AngioOCT examination inexploitable (artifact and/or image quality less than 50/100 even after pupillary dilation)
- Severe myopia (sphere \> - 6 dioptres) discovered during the ophthalmic workup. Case inclusion critera :
- Patient diagnosed with pseudoxanthoma elasticum, defined according to Plomp's criteria: two out of three features related to PXE: (1) two pathogenic mutations in the ABCC6 gene, and/or (2) disease-specific...
- Included in the PXE cohort ;
- With pre-atrophic damage, i.e. at least one eye without choroidal neovessels on OCT-A, without previous intravitreal injection of anti-VEGF, and without major retinal atrophy (less than 2 papillary diameters);
- who have had an angiographic OCT (performed during follow-up consultations) with usable results (no artifacts and image quality of 50/100 or better) ;
- patient's non-objection to participation in a study Case criteria for non-inclusion :
- Other known ophthalmological pathology (maculopathy, glaucoma, optic neuropathy, retinopathy of any etiology)
- Severe myopia, defined by a sphere \> - 6 dioptres
- Diabetic subject
The study team makes the final eligibility decision.
Where it's taking place
- Angers, 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 Angers, 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.