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Completed

NCT Number: NCT02537054

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

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.

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Key information

Conditions

Pseudoxanthoma Elasticum Angioid Streaks Cardiovascular Diseases Choroid Diseases Choroidal Neovascularization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Eye Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Diseases Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Uveal Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Ophthalmology, Universtiy of Bonn

Bonn, 53127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

Intravitreal injection

Other names: Eylea

Primary outcomes

  1. Change in distance best corrected visual acuity between end-of study visit and screening visit

    Time frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)

Secondary outcomes

  1. Change in light increment sensitivity of central visual field between end-of study visit and screening visit measured by microperimetry

    Time frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)

  2. Change in chorioretinal neovascularization and leakage measured by angiography between end-of study visit and screening visit

    Time frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)

  3. Change in sub- and intraretinal und subpigmentepithelial fluids assessed using optical coherence tomography (OCT)

    Time frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)

  4. Extent of fibrovascular proliferation on optical coherence tomography (OCT) imaging

    Time frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)

  5. Changes fundus autofluorescence images using a confocal scanning laser ophthalmoscope (cSLO)

    Time frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)

  6. Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 12 months

  7. Change in the health status of the total population measured by quality of life questionnaire Visual Function Questionnaire (VFQ)-25

    Time frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7)

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Acronym: EyNeP

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2015
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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