NCT02747030

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2017

Completed
Last Updated

January 8, 2018

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

April 18, 2016

Last Update Submit

January 4, 2018

Conditions

Central Retinal Vein Occlusion

Keywords

Central retinal vein occlusionRetinal endovascular surgeryRetinal vein cannulationOcriplasmin

Outcome Measures

Primary Outcomes (2)

  • Feasibility

    technical succes of retinal vein cannulation and duration of infusion time

    peroperative

  • Safety

    number of intervention-related (surgical or pharmacological) complications

    peroperative until 2 weeks postoperative

Secondary Outcomes (3)

  • central macular thickness

    2 weeks

  • surface of non-perfused retina

    2 weeks

  • visual acuity

    2 weeks

Study Arms (1)

Ocriplasmin intravenously

EXPERIMENTAL

All 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.

Drug: Ocriplasmin intravenously

Interventions

Ocriplasmin intravenouslyDRUG

Retinal vein cannulation with Ocriplasmin infusion

Also known as: Jetrea
Ocriplasmin intravenously

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 26310993BACKGROUND

  • 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.

    PMID: 22634985BACKGROUND

  • 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.

    PMID: 19834019BACKGROUND

  • 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.

    PMID: 19225865BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Plasminogen

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBeta-GlobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsProtein Precursors

Study Officials

  • Peter Stalmans, MD PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 21, 2016

Study Start

December 1, 2016

Primary Completion

August 10, 2017

Study Completion

August 11, 2017

Last Updated

January 8, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)