Phase I RVC With Ocriplasmin for CRVO (RVC_CRVO)

January 4, 2018 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ocriplasmin intravenously
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
Retinal vein cannulation with Ocriplasmin infusion
Other Names:
  • Jetrea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: peroperative
technical succes of retinal vein cannulation and duration of infusion time
peroperative
Safety
Time Frame: peroperative until 2 weeks postoperative
number of intervention-related (surgical or pharmacological) complications
peroperative until 2 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central macular thickness
Time Frame: 2 weeks
change in central macular thickness as measured with optical coherence tomography
2 weeks
surface of non-perfused retina
Time Frame: 2 weeks
change in surface of non-perfused retina as measured with fluo-angiography
2 weeks
visual acuity
Time Frame: 2 weeks
change in visual acuity
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

August 10, 2017

Study Completion (ACTUAL)

August 11, 2017

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (ESTIMATE)

April 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S58782

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Central Retinal Vein Occlusion

Clinical Trials on Ocriplasmin intravenously

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe