Surgical Stabilizer Assisted RVC With rtPA for CRVO

NCT03417401 | Withdrawn Phase 1 DMC

• 1 other identifier: S61283
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  7 days

• duration of infusion

  The time of infusion measured during surgery with a maximum of 10 minutes

  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)

  7 days

Secondary Outcomes (6)

• change in visual acuity after 6 to 8 weeks

  6-8 weeks

• change in central macular thickness after 6 to 8 weeks

  6-8 weeks

• intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA

  7 days

• intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA

  7 days

• intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA

  7 days

Study Arms (1)

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.

Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.; Drug: Intravenous Infusion

Interventions

Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg. PROCEDURE

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..

RVC with tPA for CRVO

Intravenous Infusion DRUG

Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).

Also known as: Recombinant tissue Plasminogen Activator (rtPA)

RVC with tPA for CRVO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Vitrectomy; Tissue Plasminogen Activator; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Peter Stalmans

  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: November 20, 2017
• First Posted: January 31, 2018
• Study Start: October 16, 2018
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)