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

NCT ID: NCT02537054

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-07-02

Brief Summary

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.

Conditions

Pseudoxanthoma Elasticum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aflibercept

2 mg/ dose (pro re nata, maximum 1 dose/ month), intravitreal use

Group Type: EXPERIMENTAL

Aflibercept

Intervention Type: DRUG

Intravitreal injection

Interventions

Aflibercept

Intravitreal injection

Intervention Type: DRUG

Other Intervention Names

Eylea

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Frank G. Holz

Prof. Dr. med. Frank G. Holz

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank G. Holz, MD, DPhil

Role: PRINCIPAL_INVESTIGATOR

University Clinic Bonn

Locations

Department of Ophthalmology, Universtiy of Bonn

Bonn, , Germany

Countries

Germany

Other Identifiers

AUG-201202-EyNeP

Identifier Type: -

Identifier Source: org_study_id