Intravitreal Aflibercept for Therapy of Patients With Pse... | NCT02537054

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

NCT02537054

Sponsor

University Hospital, Bonn

Status

Completed

Last Update Posted

May 7, 2019Actual

Enrollment

15Actual

Phase

Phase 2

Conditions

Pseudoxanthoma Elasticum

Interventions

Aflibercept

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jul 2, 2018Actual

Completion Date

Jul 2, 2018Actual

First Submitted Date

Aug 21, 2015

First Submission Date that Met QC Criteria

Aug 27, 2015

First Posted Date

Sep 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2019

Last Update Posted Date

May 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Description	Intervention Names
Aflibercept	Experimental	2 mg/ dose (pro re nata, maximum 1 dose/ month), intravitreal use	Drug: Aflibercept

Name	Type	Description	Arm Group Labels	Other Names
Aflibercept	Drug	Intravitreal injection	Aflibercept	Eylea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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)
Change in chorioretinal neovascularization and leakage measured by angiography between end-of study visit and screening visit

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011561	Pseudoxanthoma Elasticum
D020256	Choroidal Neovascularization
D000793	Angioid Streaks

ID	Term
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders