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Safety and Efficacy of Subretinal Injection of tPA in Early Submacular Hemorrhage

Clinical Study of Subretinal Injection of tPA for Early Submacular Hemorrhage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124190
Enrollment
Unknown
Registered
2026-05-08
Start date
2024-04-25
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Subretinal hemorrhage

Interventions

Subretinal tPA Injection Cohort:25G vitrectomy combined with subretinal injection of tPA (concentration 10µg/0.1ml) 0.1~0.5 ml, fully covering the hemorrhage area
after gas-fluid exchange, fill with 14%C3F8 or sterilized air

Sponsors

Shanxi Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with submacular hemorrhage of less than 2 weeks’ duration involving the fovea. 2. Patients with acute visual loss caused by hemorrhage; hemorrhage area > 1 disc diameter (DD). 3. Macular foveal elevation height > 400 µm. 4. Patients who received treatment and were followed up for more than 6 months.

Exclusion criteria

Exclusion criteria: 1. Patients with known coagulation disorders. 2. Patients with a history of vitreoretinal surgery or macular scarring. 3. Patients unable to comply with the requirement of strict prone positioning after surgery.

Design outcomes

Primary

MeasureTime frame
Best Corrected Visual Acuity (BCVA);Subretinal Hemorrhage Clearance;Central Retinal Thickness (CRT);Central Retinal Pigment Epithelium Detachment (PED) Thickness;Retinal Function;—

Countries

China

Contacts

Public ContactWang Xiaping

Shanxi Aier Eye Hospital

378074457@qq.com+86 18835130611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026