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Register:	EUCTR
Last refreshed on:	5 April 2021
Main ID:	EUCTR2006-006231-49-DE
Date of registration:	06/03/2007
Prospective Registration:	Yes
Primary sponsor:	Department of Ophthalmology, Bonn University
Public title:	Ranibizumab in choroidal neovascularization (CNV) due to Pseudoxanthoma elasticum (PXE, Groenblad-Strandberg Syndrome) - PXE-CNV 06
Scientific title:	Ranibizumab in choroidal neovascularization (CNV) due to Pseudoxanthoma elasticum (PXE, Groenblad-Strandberg Syndrome) - PXE-CNV 06
Date of first enrolment:	24/07/2007
Target sample size:	10
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006231-49
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
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

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Key inclusion & exclusion criteria

Inclusion criteria:
• 18 – 65 yrs. of age.
• PXE-diagnosis ascertained by genetic analysis.
• Angiographically diagnosed CNV in the study eye.
• Written informed consent.
• Best corrected visual acuity: 20/200 – 20/32 in the study eye.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Patients with other retinal diseases including diseases of the retinal vessels or diabetic retinopathy.
• Ocular surgery mess than three months prior to the commencment of the trial.
• History of a not well meneged glaucoma.
• Active intraocular inflammation or inflammation of the ocular adnexa.
• Subfoveal fibrosis in the study eye.
• Inability, to comply with the study protocol.
• Major surgical interventions less than 1 month prior to the commencment of the trial.
• Known allergy to humanized antibodies.
• History of clinically significant cardiovascular or cerebrovascular disease less than 6 months before commencment of the trial

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

Health Condition(s) or Problem(s) studied

Pseudoxanthoma elasticum (PXE) is an inherited systemic disease characterized by changes in the elastic tissue. Pseudoxanthoma elasticum mainly affects the skin, eyes, heart, and GI system. The cutaneous and ocular findings of PXE are referred to as Grönblad-Strandberg syndrome. Pseudoxanthoma elasticum may be autosomal dominant or autosomal recessive. In Pseudoxanthoma elasticum, choroidal nevoscualrization (CNV) is a frequently occuring complication in late stage disease
MedDRA version: 8.1 Level: LLT Classification code 10037150 Term: Pseudoxanthoma elasticum

Intervention(s)

Trade Name: Lucentis
Product Name: Lucentis
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ranibizumab
Current Sponsor code: CRFB002ADE03
Other descriptive name: RFB002, rhuFab V2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: To investigate the effect of ranibizumab on
• Vascular leakage as shown by fluorescein and indocyanin green angiography,
• Retinal thickness as shown by optical coherence tomography,
• Funduscopical/morphological aspects of the disease as documented by dilated fundus exam, auto-fluorescence and photography,
• Quality of life of the investigated sample.

Primary end point(s): • Visual acuity (as measured by the ETDRS chart at 4 meters or 1 meter distance one month after the 12th injection of Lucentis compared to the baseline visual acuity).

Main Objective: To investigate the efficacy of Ranibizumab (0.5 mg) in improving or maintaining visual acuity in choroidal neovascularization due to Pseudoxanthoma elasticum

Secondary Outcome(s)

Secondary ID(s)

CRFB002ADE03

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 24/07/2007
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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