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

Pseudoxanthoma Elasticum Clinical Trial

— EyNeP  

Official title:

Intravitreal Aflibercept (Eylea) for Therapy of Choroidal Neovascularization (CNV) and Fibrovascular Proliferation (FVP) in Patients With Pseudoxanthoma Elasticum (PXE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537054
• Other study ID #: AUG-201202-EyNeP
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: July 2, 2018

Study information

• Verified date: April 2019
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Pseudoxanthoma Elasticum

Intervention

Drug:
• Aflibercept
Intravitreal injection

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, Universtiy of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in distance best corrected visual acuity between end-of study visit and screening visit		Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)
Secondary	Change in light increment sensitivity of central visual field between end-of study visit and screening visit measured by microperimetry		Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)
Secondary	Change in chorioretinal neovascularization and leakage measured by angiography between end-of study visit and screening visit		Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)
Secondary	Change in sub- and intraretinal und subpigmentepithelial fluids assessed using optical coherence tomography (OCT)		Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)
Secondary	Extent of fibrovascular proliferation on optical coherence tomography (OCT) imaging		Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)
Secondary	Changes fundus autofluorescence images using a confocal scanning laser ophthalmoscope (cSLO)		Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)
Secondary	Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)		12 months
Secondary	Change in the health status of the total population measured by quality of life questionnaire Visual Function Questionnaire (VFQ)-25		Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)