Retinal Vein Occlusion (RVO)RVONCT07820761
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
A study of Retinal Vein Occlusion (RVO), run by University of Oxford at 1 site in United Kingdom.
Trial summary
Retinal vein occlusions (RVOs) are the second leading cause of permanent vision loss in the UK. Current treatments, like anti-VEGF injections or steroids, address complications such as macular fluid but do not target the underlying issue-a clot in the retinal vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion (RVO)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2025to 30 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Eye Research Group Oxford, Oxford Eye Hospital, LG1, West Wing of the John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Study Co-ordinator, 01865 231097, trials@eye.ox.ac.uk
About this study
Official title: Evaluating the Safety and Efficacy of Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions.
Retinal vein occlusions (RVOs) are the second leading cause of permanent vision loss in the UK. Current treatments, like anti-VEGF injections or steroids, address complications such as macular fluid but do not target the underlying issue-a clot in the retinal vein. Direct injection of clot-dissolving agents, such as tissue plasminogen activator (tPA), is challenging due to the small size of retinal veins. This surgical trial aims to inject tPA directly into the blocked retinal vein to dissolve the clot and restore blood flow.
This surgical trial aims to inject tPA directly into the blocked retinal vein to dissolve the clot and restore blood flow. Robotic assistance will stabilise the injection cannula, ensuring precise and slow infusion of tPA. This study will compare outcomes in patients receiving standard care for RVOs (the control group) with those receiving standard treatment plus the robot-assisted tPA injection (the study group). The robotic system has been clinically validated and has received CE marking for vitreoretinal interventions, including tPA injection beneath the retina.
Read more
tPA has been safely used in the eye with no reported safety concerns. It is licensed for intravenous use for thromboembolic events that lead to ischemia. RVO (an ischemic stroke of the eye) is a specific example. Instead of systemic administration through the peripheral vein, we will be directly delivering tPA into the occluded retinal vein, effectively treating the localised ischemia, within licensed intent.
40 eligible participants diagnosed with RVO will be recruited from the NHS clinic. Participants will be randomly allocated to the control group or the study group and will be monitored for 12 months. The study focuses on safety as the primary outcome and efficacy in terms of retinal structure and function as secondary outcomes. If successful, this trial could lead to a new intervention for RVO-related vision loss.
- Conditions
- Retinal Vein Occlusion (RVO)
- Being tested
- Surgery with Preceyes Robot plus NHS standard of care
- Keywords
- Ophthalmology, RVO, Retinal Vein Occlusion, Surgical Robot
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with Preceyes Robot plus NHS standard of careProcedure or surgery
Central Retinal Vein cannulation and infusion into the blocked vein using the Preceyes Robot, while following NHS standard of care
| Study group | Role | What they receive |
|---|---|---|
| Control Arm ( NHS Standard of Care Surgery) | No intervention | Participants randomised to the control arm will receive NHS standard of care surgery. |
| Interventional Arm ( NHS Standard of Care Surgery + Robot) | Active comparator | Participants randomised to the interventional arm will receive robot-assisted vein cannulation and infusion into the blocked vein during the NHS standard of care surgery. Receives: Procedure: Surgery with Preceyes Robot plus NHS standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of robot-assisted retinal vein cannulation
Evaluation of safety will be based on the potential number of procedure-related adverse events.
Measured: Baseline to 12 months
Secondary outcomes (3)
To evaluate change in visual acuity
Mean change from baseline to Month 12 in Best-Corrected Visual Acuity (BCVA) as measured by the Early Treatment of Diabetic Retinopathy (ETDRS) Chart
Measured: Baseline to 12 months
To evaluate change in central macular thickness
Mean change in central macular thickness from baseline to Month 12 as measured with spectral domain optical coherence tomography ( SD-OCT)
Measured: Baseline to 12 months
To evaluate changes in area of the non-perfused retina
Change in area of the non-perfused retina from baseline to Month 12 as measured with fundus fluorescein angiography (FFA).
Measured: At all protocol-specified visits with the endpoint at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Sep 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein Occlusion (RVO)Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820761
- Sponsor's protocol ID
- 18754
- Other IDs
- 34223
- Acronym
- RVO
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided