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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University Hospital, Bonn

Current Primary Outcome: 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) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 12 months ]
  • 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) ]


Original Secondary Outcome:

  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 12 months ]
  • Change in the health status of the total population measured by quality of life questionnaire VFQ-25 [ Time Frame: Screening visit (day -28 - 0) and end-of-study visit (day 360 +/- 7) ]


Information By: University Hospital, Bonn

Dates:
Date Received: August 21, 2015
Date Started: September 2015
Date Completion: February 2018
Last Updated: September 18, 2016
Last Verified: September 2016