Central Retinal Vein OcclusionPhase 1NCT03417401
Surgical Stabilizer Assisted RVC With rtPA for CRVO
A Phase 1 study testing Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg. and Intravenous Infusion in people with Central Retinal Vein Occlusion, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This phase Ib study investigates the safety and efficacy of performing a retinal vein cannulation with recombinant tissue Plasminogen Activator infusion into a retinal vein with the help of an updated dedicated surgical stabiliser for the treatment of central retinal vein occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg. and Intravenous Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2018to 10 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients aged over 18 years
- Recent diagnosis (<8 weeks) of CRVO
- Recent onset of symptoms (<12 weeks)
- Visual acuity < 5/10 in study eye
- Visual acuity >1/10 in fellow eye
- Central macular thickness >250µm
- Signed informed consent prior to inclusion
Who cannot join
- Fluorescein allergy
- Active neovascularization
- Eye disease other than CRVO or Cataract decreasing central vision
- History of retinal surgery
- High myopia (> -10D)
- Contraindication for the use of systemic anticoagulant medication
- Extensive macular ischemia noted on fluo-angiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation (RVC) With tPA Infusion Confirmed by Intraoperative Angio-optical Coherence Tomography (Angio-OCT) for the Treatment of Central Retinal Vein Occlusion (CRVO).
This phase Ib study investigates the safety and efficacy of performing a retinal vein cannulation with recombinant tissue Plasminogen Activator infusion into a retinal vein with the help of an updated dedicated surgical stabiliser for the treatment of central retinal vein occlusion.
Read the detailed description
Investigator-initiated, unmasked, single-arm, mono-center, prospective, interventional case series phase Ib trial. In line with the previous phase I trial, this trial will be biphasic; first 3 patients will be included, when the procedure and product prove to be safe and an added value is noted from the intra-operative OCT-angiography, another 3 will be included afterwards (≥21 days between last inclusion of the first group and first inclusion of the second group).
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg., Intravenous Infusion
- 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.
Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.Procedure or surgery
Standard 3-port pars plana vitrectomy with surgical stabilizer assisted ( surgical robot) retinal vein cannulation with recombinant tissue Plasminogen Activator (Actilyse-0.25mg/ml) infusion with a maximal dose of 1mg..
Intravenous InfusionDrug
Also called Recombinant tissue Plasminogen Activator (rtPA)
Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).
| Study group | Role | What they receive |
|---|---|---|
| RVC with tPA for CRVO | Experimental | Single arm phase I open label study were CRVO patients will have a vitrectomy with retinal vein cannulation and a single infusion of tPA (0.25mg/ml) intravenously with a maximum dose of 1mg. Receives: Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.; Drug: Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of retinal vein cannulation
successful cannulation defined as peroperatively seen washout of blood in the cannulated retinal vein. The success rate is defined as the number of successful cannulations divided by the total number of cannulation attempts.
Measured: 10 min
number of intervention-related surgical complications
These exist of the intra-operative occurence of:
- retinal vein tear (visually seen by the surgeon)
- uncontrollable vitreous cavity hemorrhage (as seen by the surgeon)
- retinal tear in the proximity of the cannulation site (as seen by the surgeon)
- intra-/subretinal injection (as seen by the surgeon)
- breakage of the needle (as seen by the surgeon)
- failure of stabilizer in holding the instrument immobilized in a certain position (as seen by the surgeon)
Measured: 7 days
duration of infusion
The time of infusion measured during surgery with a maximum of 10 minutes
Measured: 10 minutes
number of intervention-related non-surgical complications
The postoperative occurence of:
- hemorrhagic cerebrovascular accidents due to rtPA (confirmed by CT-scan and neurological examination after referral to the neurologist)
- large hemorrhage elsewhere to be related with the use of rtPA (as confirmed by clinical examination and/or CT-scan/ultrasound after referral to vascular surgeon)
Measured: 7 days
Secondary outcomes (6)
change in visual acuity after 6 to 8 weeks
best corrected visual acuity tested with ETDRS chart
Measured: 6-8 weeks
change in central macular thickness after 6 to 8 weeks
measurement of central macular thickness with spectral domain-OCT
Measured: 6-8 weeks
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
- complications of intraocular surgery:
- wound leak tested with concentrated fluorescein (Seidel effect present/absent)
- endophthalmitis as seen with the slit lamp/ultrasonography
- post-operative macular edema objectivated with OCT imaging
- vitreous hemorrhage > 2 weeks after intervention as seen at the slit lamp and confirmed with ultrasonography
- development of neovascularization as seen at the slit lamp / fluorescein angiogram
Measured: 7 days
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
- complications during cataract surgery:
- iris hemorrhage as seen through the surgical microscope (present/absent)
- choroidal swelling as seen through the surgical microscope (present/absent)
- suprachoroidal hemorrhage as seen through the surgical microscope (present/absent)
- capsule tear as seen through the surgical microscope (present/absent)
- dropped lens/intraocular lens (IOL). Recombinant tissue Plasminogen Activator (rtPA) as seen through the surgical microscope (occurred/not occurred)
Measured: 7 days
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
- complications during vitrectomy:
- retinal tears as seen through the surgical microscope (occurred/not occurred)
- vitreous hemorrhage as seen through the surgical microscope (occurred/not occurred)
- choroidal swelling as seen through the surgical microscope (present/absent)
- suprachoroidal hemorrhage as seen through the surgical microscope (present/absent)
Measured: 7 days
change in retinal flow intraoperatively visualized with OCT-angiography
OCT-angiography visualized flow inside the retinal veins with the intraoperative OCT device; if there is flow the blood vessel is imaged in bright white, if there is no flow the blood vessel is not visible with angio-OCT.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start16 Oct 2018 (estimated)
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Why it stopped: organizationally not yet possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417401
- Sponsor's protocol ID
- S61283
- Status last verified
- Mar 2023
- First submitted
- 20 Nov 2017
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation (RVC) With tPA Infusion Confirmed by Intraoperative Angio-optical Coherence Tomography (Angio-OCT) for the Treatment of Central Retinal Vein Occlusion (CRVO).
- ClinicalTrials.gov ID
- NCT03417401
- Acronym / sponsor ID
- S61283
- Conditions
- Central Retinal Vein Occlusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: organizationally not yet possible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 16 Oct 2018 (estimated)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase Ib study investigates the safety and efficacy of performing a retinal vein cannulation with recombinant tissue Plasminogen Activator infusion into a retinal vein with the help of an updated dedicated surgical stabiliser for the treatment of central retinal vein occlusion.
Detailed description
Investigator-initiated, unmasked, single-arm, mono-center, prospective, interventional case series phase Ib trial. In line with the previous phase I trial, this trial will be biphasic; first 3 patients will be included, when the procedure and product prove to be safe and an added value is noted from the intra-operative OCT-angiography, another 3 will be included afterwards (≥21 days between last inclusion of the first group and first inclusion of the second group).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RVC with tPA for CRVO | Experimental | Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg., Drug: Intravenous InfusionSingle arm phase I open label study were CRVO patients will have a vitrectomy with retinal vein cannulation and a single infusion of tPA (0.25mg/ml) intravenously with a maximum dose of 1mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged over 18 years
- Recent diagnosis (<8 weeks) of CRVO
- Recent onset of symptoms (<12 weeks)
- Visual acuity < 5/10 in study eye
- Visual acuity >1/10 in fellow eye
Key exclusion criteria (7 listed)
- Fluorescein allergy
- Active neovascularization
- Eye disease other than CRVO or Cataract decreasing central vision
- History of retinal surgery
- High myopia (> -10D)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.Standard 3-port pars plana vitrectomy with surgical stabilizer assisted ( surgical robot) retinal vein cannulation with recombinant tissue Plasminogen Activator (Actilyse-0.25mg/ml) infusion with a maximal dose of 1mg.. | Procedure or surgery | RVC with tPA for CRVO |
| Intravenous InfusionAlso: Recombinant tissue Plasminogen Activator (rtPA)Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml). | Drug | RVC with tPA for CRVO |
Primary outcome
Success rate of retinal vein cannulation
Time frame: 10 min
successful cannulation defined as peroperatively seen washout of blood in the cannulated retinal vein. The success rate is defined as the number of successful cannulations divided by the total number of cannulation attempts.
number of intervention-related surgical complications
Time frame: 7 days
These exist of the intra-operative occurence of: * retinal vein tear (visually seen by the surgeon) * uncontrollable vitreous cavity hemorrhage (as seen by the surgeon) * retinal tear in the proximity of the cannulation site (as seen by the surgeon) * intra-/subretinal injection (as seen by the surgeon) * breakage of the needle (as seen by the surgeon) * failure of stabilizer in holding the instrument immobilized in a certain position (as seen by the surgeon)
duration of infusion
Time frame: 10 minutes
The time of infusion measured during surgery with a maximum of 10 minutes
number of intervention-related non-surgical complications
Time frame: 7 days
The postoperative occurence of: * hemorrhagic cerebrovascular accidents due to rtPA (confirmed by CT-scan and neurological examination after referral to the neurologist) * large hemorrhage elsewhere to be related with the use of rtPA (as confirmed by clinical examination and/or CT-scan/ultrasound after referral to vascular surgeon)
6 secondary outcomes
change in visual acuity after 6 to 8 weeks
Time frame: 6-8 weeks
change in central macular thickness after 6 to 8 weeks
Time frame: 6-8 weeks
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
Time frame: 7 days
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
Time frame: 7 days
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
Time frame: 7 days
change in retinal flow intraoperatively visualized with OCT-angiography
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stalmans principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg. and Intravenous Infusion in people with Central Retinal Vein Occlusion, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of retinal vein cannulation (time frame: 10 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.