Application of tPA in Suprachoroidal and Subretinal Hemorrhage

Severe ocular rupture may be accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage. The suprachoroidal hemorrhage needs to be drained as soon as possible. In the process of waiting for the spontaneous liquefaction of hemorrhage, uncontrollable elevated intraocular pressure may occur, resulting in optic nerve injury, optic nerve atrophy, and visual loss. Tissue plasminogen activator can promote the liquefaction of blood clots. Studies have found that local application of tissue plasminogen activator in the suprachoroidal space can promote the liquefaction of the hemorrhage. Local application of tissue fibrinogen activator under the retina can promote the liquefaction of subretinal hemorrhage.

Study Overview

• Status: Recruiting
• Conditions: Ocular Trauma
• Intervention / Treatment: Drug: Tissue Plasminogen Activator

Detailed Description

Severe ocular rupture may be accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage. The suprachoroidal hemorrhage needs to be drained as soon as possible. The traditional treatment method needs to wait for the spontaneous liquefaction of the suprachoroidal hemorrhage, and then perform scleral incision to drain the liquefied suprachoroidal hemorrhage. However, in the process of waiting for the spontaneous liquefaction of suprachoroidal hemorrhage, uncontrollable elevated intraocular pressure may occur, resulting in optic nerve injury, optic nerve atrophy, and visual loss. In addition, if the suprachoroidal hemorrhage is not completely liquefied, it will not be completely drained, which will lead to choroidal function damage, low intraocular pressure and eyeball atrophy.

Severe ocular rupture can be accompanied by a large amount of subretinal hemorrhage. The traditional treatment is to open the retina in a large area and drain the subretinal hemorrhage. However, extensive retinal incision has great damage, vitreoretinal proliferation often occurs after surgery, leading to recurrent retinal detachment, large area of choroid exposure, low intraocular pressure, and atrophy of the eye.

Tissue plasminogen activator can promote the liquefaction of blood clots. Studies have found that local application of tissue plasminogen activator in the suprachoroidal space can promote the liquefaction of the hemorrhage near the suprachoroidal space, and can drain the hemorrhage of the suprachoroidal space smoothly and completely in the early stage. Local application of tissue plasminogen activator under the retina can promote the liquefaction of subretinal hemorrhage. Through small retinal incision, subretinal hemorrhage can be completely drained, the scope of retinal incision can be reduced, vitreoretinal proliferation can be reduced, and the occurrence of recurrent retinal detachment after surgery can be reduced.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhitao Su, Ph.D; Phone Number: 86 0571 87783759; Email: suzhitao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Zhitao Su, Ph.D; Phone Number: 86 0571 87783759; Email: suzhitao@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with severe ocular rupture accompanied by suprachoroidal hemorrhage, or subretinal hemorrhage, or with suprachoroidal hemorrhage and subretinal hemorrhage

Exclusion Criteria:

• Rupture of eyeball accompanied by a small amount of suprachoroidal hemorrhage or a small amount of subretinal hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Control group (no tissue fibrinogen activator)
Experimental: Drug group; Drug group (injection of 50 ug tissue fibrinogen activator into the suprachoroidal cavity or subretinal space )	Drug: Tissue Plasminogen Activator; Injection of 50 ug tissue plasminogen activator into the suprachoroidal cavity or subretinal space to assist in bleeding liquefaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Best corrected visual acuity	through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	Intraocular pressure	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

Helpful Links

• Tissue plasminogen activator-assisted vitrectomy for ruptured eye with suprachoroidal hemorrhage
• Tissue plasminogen activator-assisted vitrectomy in the early treatment of acute massive suprachoroidal hemorrhage complicating cataract surgery
• Recombinant tissue plasminogen activator in the treatment of suprachoroidal hemorrhage
• Tissue plasminogen activator in the treatment of vitreoretinal diseases
• Treatment of suprachoroidal hemorrhage with tissue plasminogen activator
• Treatment of experimental suprachoroidal hemorrhage with intravenous tissue plasminogen activator

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): July 31, 2026

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Estimate): February 21, 2023

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: suprachoroidal hemorrhage; subretinal hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: 2022-0178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No