Robotic-assisted tPA injection for retinal vein occlusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares standard care for retinal vein occlusion with an approach that uses a robotic system to precisely inject tPA into the blocked retinal vein. The goal is to dissolve the clot and improve retinal blood flow while monitoring safety and vision-related outcomes. Patients eligible are adults with recent central RVO and certain vision criteria, and procedures involve the Preceyes robot in addition to usual care. The study builds on prior clinical validation of the robotic system for delicate ophthalmic procedures. Outcomes will inform whether robot-assisted targeted thrombolysis can offer additional benefit over standard treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant is wiling and able to give informed consent for participation in the trial
* Male or Female aged 18 years or above
* Recently diagnosed with central RVO (\<4 weeks)
* In the Investigator's opinion, the patient is able and willing to comply with all trial requirements and is deemed fit for treatment.
* ETDRS BCVA letter score of 70 or less or Snellen equivalent (\< 6/12) in the study eye at Screening Visit 1

Exclusion Criteria:

* Participants with comorbidities contraindicating vitreoretinal surgery (e.g. excessive tremor) as determined by the investigator.
* Participants with ocular comorbidities contraindicating the use of steroid implants (e.g. glaucoma) or anti-VEGFs as determined by the investigator.
* Participants who are participating in another research trial involving an investigational product or surgical intervention.
* Participants with known allergy to Fluorescein
* Participants with contraindications for the use of tPA (Alteplase, Boehringer Ingelheim, Germany) or currently receiving or starting medications that have a known interaction with tPA, as identified in the SmPC, which may alter its efficacy or safety profile of tPA.

Where it's running

• Eye Research Group Oxford, Oxford Eye Hospital, LG1, West Wing of the John Radcliffe Hospital
  Oxford, Oxfordshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Study Co-ordinator
• Email: trials@eye.ox.ac.uk
• Phone: 01865 231097

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.