Intravitreal Aflibercept for Therapy of Patients With Pseudoxanthoma Elasticum (PXE) (EyNeP)

University Hospital Bonn (UKB)

Status and phase

Completed

Phase 2

Conditions

Pseudoxanthoma Elasticum

Treatments

Drug: Aflibercept

Study type

Interventional

Funder types

Other

Identifiers

NCT02537054

AUG-201202-EyNeP

Details and patient eligibility

About

The purpose of this study is to determine whether Aflibercept (Eylea) is effective in the treatment of choroidal neovascularization and fibrovascular proliferation in patients with pseudoxanthoma elasticum (PXE) in terms of preservation or improvement of visual acuity.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of PXE by moleculargenetic diagnosis and/or skin biopsy
Diagnosed CNV or FVP
Age 18-65 years
Voluntary participation in this study as proven by written informed consent
Ability to follow study instructions and likely to attend and complete all required visits
Best corrected visual acuity between 20/400 and 20/20 at treated eye
Male and female patients with childbearing potential must use an approved contraceptive method (Pearl Index < 1) before and during the trial
Pre-menopausal female patients with childbearing potential: a negative pregnancy test must be obtained

Exclusion criteria

Subject is unable to understand the nature, scope, significance and consequences of this clinical trial
Patients with known allergy or hypersensitivity to Eylea or preparations with similar chemical structure
Treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial of within 30 days before enrolment
Known or persistent abuse of medication, drugs or alcohol
Women who are pregnant or breast feeding
Lack of eligibility at discretion of the investigator
Ocular operations within a month prior to enrolment
Non-controlled glaucoma
Active intraocular inflammation or inflammation of ocular adnexa
Other diseases resulting in distinct visual constraint
Distinct opacification of optical media
Distinct subretinal fibrosis and /or atrophy that prevents a relevant treatment effect by Aflibercept at discretion of investigator
Serious cardiovascular problems or stroke within 6 months before enrolment
Simultaneous use of other Vascular Endothelial Growth Factor (VEGF)-inhibiting medication (systemic or ocular) within a month prior to enrolment