Choriocapillaris blood flow differences in people with pseudoxanthoma elasticum versus healthy adults
CHOPXE - Analysis of Choriocapillaris Flow Deficits in Patients With Pseudoxanthoma Elasticum
We will test whether a noninvasive eye scan (OCT angiography) shows reduced choriocapillaris blood flow in adults with pseudoxanthoma elasticum compared with matched healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 1 site (Angers) |
| Trial ID | NCT07006649 on ClinicalTrials.gov |
What this trial studies
CHOPXE is a single-center, case-control, cross-sectional study that compares choriocapillaris flow deficits measured by OCT angiography between adults with pseudoxanthoma elasticum (PXE) and age- and sex-matched healthy controls. Participants undergo standardized ophthalmic imaging to quantify flow deficits in the choriocapillaris layer. Cases are recruited from patients with PXE in pre-atrophic stages, and controls must have no ophthalmic pathology, severe myopia, or diabetes. The study aims to determine whether OCT-A measurements could serve as an objective marker of early PXE-related retinal and choroidal changes.
Who should consider this trial
Good fit: Ideal candidates are adults with genetically confirmed or clinically diagnosed PXE in pre-atrophic stages, and age- and sex-matched healthy adults without eye disease who can undergo OCT-A imaging and provide informed consent.
Not a fit: Patients with existing ophthalmic diseases (maculopathy, glaucoma, optic neuropathy, retinopathy), severe myopia, diabetes, pregnancy, or inability to complete imaging are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, OCT-A choriocapillaris measurements could become an objective early marker to track PXE progression and help guide monitoring and treatment decisions.
How similar studies have performed: OCT-A has revealed choriocapillaris flow deficits in other retinal degenerations, but its use specifically as an objective marker in PXE remains limited and exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 inclusion Criteria for non-inclusion of research subjects * 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 Exclusion Criteria: * 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 dermatological changes and/or (3) disease-specific ocular changes; * 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
Where this trial is running
Angers
- Angers University Hospital — Angers, France (Recruiting)
Study contacts
- Principal investigator: Laurie MOUROZEAU, Doctor — University Hospital, Angers
- Study coordinator: Laurie MOUROZEAU, Doctor
- Email: Laurie.Mourozeau@chu-angers.fr
- Phone: +33 (0)2 41 35 32 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.