Pilot study on robot assisted retinal vein cannulation with ocriplasmin infusion for central retinal vein occlusion.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005473-20-BE

Enrollment

Unknown

Registered

2015-12-10

Start date

2016-11-23

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with central retinal vein occlusion (CRVO)

Interventions

Trade Name: Jetrea Product Name: Jetrea Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients aged over 18 years • Recent diagnosis of CRVO • Onset of symptoms 1/10 in fellow eye • Central macular thickness >250µm and =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: This study aims at investigating the therapeutic effect of local intravenous administration of ocriplasmin in patients with a central retinal vein occlusion. The primary outcome measure is change in visual acuity after 6 months ;Secondary Objective: - change in central macular thickness after 6 months - change in surface of non-perfused retina - number of intravitreal antiVEGF/ corticosteroid treatments during 6 months - number of retinal laser treatments during 6 months - intra-/postoperative complications ;Primary end point(s): • Change in visual acuity;Timepoint(s) of evaluation of this end point: First analysis: 1 month after treatment of the last enrolled patient Final analysis: 6 months after the last treatment of the last enrolled patient	—

Measure

Time frame

Main Objective: This study aims at investigating the therapeutic effect of local intravenous administration of ocriplasmin in patients with a central retinal vein occlusion. The primary outcome measure is change in visual acuity after 6 months ;Secondary Objective: - change in central macular thickness after 6 months - change in surface of non-perfused retina - number of intravitreal antiVEGF/ corticosteroid treatments during 6 months - number of retinal laser treatments during 6 months - intra-/postoperative complications ;Primary end point(s): • Change in visual acuity;Timepoint(s) of evaluation of this end point: First analysis: 1 month after treatment of the last enrolled patient Final analysis: 6 months after the last treatment of the last enrolled patient

—

Secondary

Measure	Time frame
Secondary end point(s): • Change in central macular thickness • Change in surface of non-perfused retina • Change in retinal perfusion times as assessed by fluo angiography • Number of intra-/postoperative complications • Number of intravitreal injected antiVEGF/steroids • Number of additional (postoperative) retinal laser treatments ;Timepoint(s) of evaluation of this end point: First analysis: 1 month after treatment of the last enrolled patient Final analysis: 6 months after the last treatment of the last enrolled patient	—

Measure

Time frame

Secondary end point(s): • Change in central macular thickness • Change in surface of non-perfused retina • Change in retinal perfusion times as assessed by fluo angiography • Number of intra-/postoperative complications • Number of intravitreal injected antiVEGF/steroids • Number of additional (postoperative) retinal laser treatments ;Timepoint(s) of evaluation of this end point: First analysis: 1 month after treatment of the last enrolled patient Final analysis: 6 months after the last treatment of the last enrolled patient

—

Countries

Belgium

Contacts

Public ContactPeter Stalmans

UZ Leuven

peter.stalmans@uzleuven.be3216341819

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026