Ranibizumab to Treat Choroidal Neovascularization (CNV) in Patients With Pseudoxanthoma Elasticum (PXE)

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in the treatment of choroidal neovascularization in underlying angioid streaks due to Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye over a period of one year.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bonn
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Diagnosis of choroidal neovascularization in patients with pseudoxanthoma elasticum

• Age between 18-65 years

• Patient must be able to follow protocol

• Written informed consent

• Genetic diagnosis of pseudoxanthoma elasticum

• Best corrected visual acuity between 20/200 - 20/32 in the treated eye

Exclusion Criteria:

• Patients who do not fulfill the inclusion criteria

• Patients with other retinal vascular diseases such as diabetic retinopathy or venous occlusive disease

• Ocular surgery 3 months before study enrollment

• History of uncontrolled glaucoma

• Active intraocular inflammation or inflammation of the ocular adnexa

• Subfoveal fibrosis in the study eye

• Inability to follow study protocol

• Major surgery one month before study enrollment

• History of severe cardiovascular disease or history of stroke 6 months before study enrollment

• Allergies against the substances or components of the study medication

• Low anticipated compliance

• Patients who participated in clinical trials simultaneously or within the last 60 days

• Pregnancy, lactation, women that may become pregnant and don't use safe contraception

• Chronic alcohol- or drug abuse within the last year

• Lacking legal competence or language ability

• Neurologic diseases such as multiple sclerosis

• Need of concomitant medication that is not allowed in combination with ranibizumab

• Previous intravitreal therapy with anti-angiogenic substances in the study eye within the last 6 months