CompletedPhase 1

Phase I RVC With Ocriplasmin for CRVO

Belgium4 participantsStarted 2016-12

Plain-language summary

In central retinal vein occlusion (CRVO) a blood clot blocks the venous outflow of the entire retinal circulation. This leads to retinal and vitreous hemorrhages, retinal edema and neovascularization. The development of a microneedle and surgical stabilizer made it possible to perform a prolonged (10 minutes) retinal vein cannulation with infusion of Ocriplasmin. Ocriplasmin has the advantage over tissue Plasminogen Activator (tPA) that it already is an active enzyme and a strong fibrinolyticum. This study aims to investigate the feasibility and safety of local intravenous Ocriplasmin for CRVO.

Who can participate

Age range

18 Years – 100 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: * Patients aged over 18 years * Recent diagnosis of CRVO * Onset of symptoms \<10 days * Visual acuity \< 2/10 in study eye * Visual acuity \>1/10 in fellow eye * Central macular thickness \>250µm and \<1000 µm * Signed informed consent prior to inclusion Exclusion Criteria: * Fluorescein allergy * Active neovascularization (NVD/NVE/NVI/NVA) * Eye disease other than CRVO or Cataract decreasing vision * Use of acetazolamide or other drugs potentially affecting macular edema, including systemic steroids \>10mg/d * History of retinal surgery * High myopia (\> -10D) * Contraindication for the use of systemic anticoagulant medication

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

Feasibility

Timeframe: peroperative

Safety

Timeframe: peroperative until 2 weeks postoperative

Trial details

NCT IDNCT02747030

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-10

View on ClinicalTrials.gov More Central Retinal Vein Occlusion trials