EUCTR2006-006231-49-DE
Active, not recruiting
Phase 1
Ranibizumab in choroidal neovascularization (CNV) due to Pseudoxanthoma elasticum (PXE, Groenblad-Strandberg Syndrome) - PXE-CNV 06
Department of Ophthalmology, Bonn University0 sites10 target enrollmentMarch 6, 2007
ConditionsPseudoxanthoma 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 diseaseMedDRA version: 8.1Level: LLTClassification code 10037150Term: Pseudoxanthoma elasticum
DrugsLucentis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 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
- Sponsor
- Department of Ophthalmology, Bonn University
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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