CompletedPhase 2

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

Germany10 participantsStarted 2007-08

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best corrected visual acuity

Timeframe: one year

Trial details

NCT IDNCT00510965

SponsorUniversity Hospital, Bonn

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

View on ClinicalTrials.gov More Choroidal Neovascularization trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.