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Central Retinal Vein OcclusionPhase 1RVC_CRVONCT02747030

Phase I RVC With Ocriplasmin for CRVO

A Phase 1 study testing Ocriplasmin intravenously in people with Central Retinal Vein Occlusion, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Central Retinal Vein Occlusion
What is being tested?
Ocriplasmin intravenously
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteBelgium
Study dates
Dec 2016to 11 Aug 2017
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

Official title: Phase I Study on the Feasibility and Safety of Surgical Stabilizer Assisted Retinal Vein Cannulation With Ocriplasmin Infusion for Central Retinal Vein Occlusion.

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.

Read the detailed description

Central retinal vein occlusion (CRVO) is the second most common source of permanent blindness in the Western world after diabetic retinopathy. By blocking the outflow pathway for the retinal circulation, visual prognosis is bad on the short and long term. Currently, treatment is mostly focused on treating the secondary effects: macular edema and neovascularization with antiVEGF and/or corticosteroid intravitreal injections and retinal laser photocoagulation. There is however a surgical treatment aimed at displacing the blood clot; a radial optic neurotomy. During this surgical treatment, the vitreous is removed by vitrectomy, after which a radial incision is made in the optic disc. The target of this incision is to open the canal in the lamina cribrosa to improve the blood flow in the central retinal vein. Since the outcome of this procedure is variable and has its inherent risks, mainly because the incision can damage the central retinal artery which is adjacent to the central vein, this procedure is not routinely performed in all vitreoretinal centers.

Following the recent development of a surgical stabilizer and microneedle suitable for retinal vein cannulations, the option for local intravenous administration of fibrinolytic drugs exists. This phase I study aims to investigate the feasibility and safety of surgical stabilizer assisted retinal vein cannulation with local intravenous infusion of Ocriplasmin to dissolve the clot clogging the central retinal vein. Ocriplasmin is the small active part of the larger plasmin molecule. Plasmin itself is formed by enzymatic conversion from plasminogen, a process that is mediated by tissue plasminogen activator (tPA). The amount of plasmin that can be produced is thus highly dependent on the amount of plasminogen that is present nearby the clot. By using Ocriplasmin, this intermediate step can be skipped and the clot will be targeted directly and during the entire time of infusion. By being able to get infusion times up to 10 minutes, abundant clot exposure to Ocriplasmin is guaranteed.

Inclusion will be offered to patients presenting with a recent CRVO, a vitrectomy will be performed augmented with retinal vein cannulation and infusion of ocriplasmin during 10 minutes.

Patients presenting with a recent CRVO (<2weeks) will be offered inclusion to undergo a vitrectomy with subsequent prolonged retinal vein cannulation and infusion of Ocirplasmin. The surgery is done by placing a microneedle in one of the branch retinal veins at the border of the optic disc. To increase the safety of this procedure a surgical stabilizer was developed. This procedure was abundantly tested and refined in multiple in vivo porcine experiments and the medication (Ocriplasmin) has already been tested for fibrinolytic activity used in 100-fold higher dosis intravenously and intra-arterially.

After the surgery, standard of care follow up with a comprehensive ophthalmological examination and technical investigations is foreseen. The primary outcome measures of this safety and feasiblity study are: technical success to cannulate the retinal vein and inject ocriplasmin to remove the blood clot, number of intervention-related (surgical or pharmacological) complications, duration of infusion.

If necessary; depending on the disease evolution, additional interventions like intravitreal antiVEGF, steroids or laser photocoagulation can be performed.

Being tested
Ocriplasmin intravenously
Keywords
Central retinal vein occlusion, Retinal endovascular surgery, Retinal vein cannulation, Ocriplasmin
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.

  • Ocriplasmin intravenouslyDrug

    Also called Jetrea

    Retinal vein cannulation with Ocriplasmin infusion

Study groups in NCT02747030
Study groupRoleWhat they receive
Ocriplasmin intravenouslyExperimentalAll subjects included in this phase I study are in the experimental treatment arm and will undergo a vitrectomy augmented with retinal vein cannulation and intravenous Ocriplasmin infusion.
Receives: Drug: Ocriplasmin intravenously

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    technical succes of retinal vein cannulation and duration of infusion time

    Measured: peroperative

  2. Safety

    number of intervention-related (surgical or pharmacological) complications

    Measured: peroperative until 2 weeks postoperative

Secondary outcomes (3)

  1. central macular thickness

    change in central macular thickness as measured with optical coherence tomography

    Measured: 2 weeks

  2. surface of non-perfused retina

    change in surface of non-perfused retina as measured with fluo-angiography

    Measured: 2 weeks

  3. visual acuity

    change in visual acuity

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion10 Aug 2017
  4. Study completion11 Aug 2017

Resources

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747030
Sponsor's protocol ID
S58782
Acronym
RVC_CRVO
Status last verified
Nov 2017
First submitted
18 Apr 2016
Last updated
8 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • van Overdam KA, Missotten T, Spielberg LH. Updated cannulation technique for tissue plasminogen activator injection into peripapillary retinal vein for central retinal vein occlusion. Acta Ophthalmol. 2015 Dec;93(8):739-44. doi: 10.1111/aos.12830. Epub 2015 Aug 27.

    PubMed 26310993

  • Verhamme P, Heye S, Peerlinck K, Cahillane G, Tangelder M, Fourneau I, Daenens K, Belmans A, Pakola S, Verhaeghe R, Maleux G. Catheter-directed thrombolysis with microplasmin for acute peripheral arterial occlusion (PAO): an exploratory study. Int Angiol. 2012 Jun;31(3):289-96.

    PubMed 22634985

  • Thijs VN, Peeters A, Vosko M, Aichner F, Schellinger PD, Schneider D, Neumann-Haefelin T, Rother J, Davalos A, Wahlgren N, Verhamme P. Randomized, placebo-controlled, dose-ranging clinical trial of intravenous microplasmin in patients with acute ischemic stroke. Stroke. 2009 Dec;40(12):3789-95. doi: 10.1161/STROKEAHA.109.560201. Epub 2009 Oct 15.

    PubMed 19834019

  • Verhamme P, Jerome M, Goossens G, Devis J, Maleux G, Stas M. A pilot trial of microplasmin in patients with long-term venous access catheter thrombosis. J Thromb Thrombolysis. 2009 Nov;28(4):477-81. doi: 10.1007/s11239-009-0310-x. Epub 2009 Feb 19.

    PubMed 19225865

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ocriplasmin intravenously 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: finished, as of the sponsor's last update on 8 Jan 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility (time frame: peroperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02747030, which also lists 4 linked publications.

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 8 Jan 2018.

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