Intravitreal Aflibercept (Eylea®) for therapy of choroidal neovascularization and fibrovascular proliferation in patients with Pseudoxanthoma elasticum

• Register: EUCTR
• Last refreshed on: 7 December 2020
• Main ID: EUCTR2014-005263-33-DE
• Date of registration: 26/02/2015
• Prospective Registration: Yes
• Primary sponsor: Medizinische Fakultät der Universität Bonn
• Public title: Intravitreal Aflibercept (Eylea®) for therapy of choroidal neovascularization and fibrovascular proliferation in patients with Pseudoxanthoma elasticum
• Scientific title: Intravitreal Aflibercept (Eylea®) for therapy of choroidal neovascularization and fibrovascular proliferation in patients with Pseudoxanthoma elasticum - EyNeP
• Date of first enrolment: 29/04/2015
• Target sample size: 15
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005263-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Dr. med. Christoph Coch
• Affiliation: Studienzentrale SZB

• Name: Dr. med. Christoph Coch
• Affiliation: Studienzentrale SZB

Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Choroidal neovascularizations and fibrovascular proliferations in patients with Pseudoxanthoma elasticum
MedDRA version: 20.0 Level: PT Classification code 10037150 Term: Pseudoxanthoma elasticum System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: Eylea
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Secondary Objective:

Main Objective:

Primary end point(s):

Secondary ID(s)

AUG-201202-EyNeP

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date: 20/04/2015
Contact: