NIPH Clinical Trials Search

Efficacy and Safety of Tissue Plasminogen Activator (Monteplase) for Submacular Hemorrhage

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Submacular hemorrhage due to age-related macular degeneration or retinal arterial macroaneurysm
Date of first enrollment	01/08/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	After performing vitrectomy on enrolled subjects, 0.1 mL (8,000 IU) of monteplase (recombinant) diluted to 80,000 IU/mL will be administered subretinally.

Outcome(s)

Primary Outcome

Change in central foveal retinal thickness from baseline at Week 1.

Secondary Outcome

1) Change in central foveal retinal thickness from baseline at Week 4. 2) Presence or absence of a foveal hemorrhage of one disc diameter or larger at Week 4. 3) Best-corrected visual acuity (BCVA) in logMAR at Week 4. 4) Change in best-corrected visual acuity (BCVA) in logMAR from baseline at Week 4. 5) Change in central foveal retinal thickness from baseline at Week 12. 6) Best-corrected visual acuity (BCVA) in logMAR at Week 12. 7) Change in best-corrected visual acuity (BCVA) in logMAR from baseline at Week 12.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients who are 18 years of age or older at the time of signing the informed consent form. 2) Patients with submacular hemorrhage (SMH) involving the fovea in the study eye secondary to AMD (age-related macular degeneration) or RAM (retinal arterial microaneurysm). 3) Patients with a central retinal thickness of 300 micrometer or more in the study eye as measured by OCT at the time of screening. 4) Patients with a best-corrected visual acuity (BCVA) of 0.2 or less (decimal notation) in the study eye at the time of screening. 5) Patients who can provide written informed consent for study participation; however, if visual impairment makes it difficult to read the document, consent may be confirmed verbally in the presence of a witness who will sign on behalf of the patient.
Exclude criteria	1) Patients who, at the time of screening, are determined by the principal investigator or sub-investigator to have significant organization or fibrosis due to prolonged SMH. 2) Patients who, at the time of screening, have coexisting active proliferative diabetic retinopathy, uveitis, or optic neuritis. 3) Patients who, at the time of screening, are determined by the principal investigator or sub-investigator to have ocular complications such as macular atrophy or fibrosis that make visual improvement difficult. 4) Patients who, at the time of screening, have anterior segment or vitreous abnormalities that affect fundus observation by OCT, color fundus photography, or fluorescein angiography. 5) Patients with a known allergy to any component of the investigational drug or a history of such an allergy. 6) Patients with alcohol or drug dependence, or those with psychiatric disorders that may interfere with study participation. 7) Patients scheduled to undergo ophthalmic surgery other than the administration of the investigational drug during the study period. 8) Patients with active bleeding (e.g., gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial hemorrhage, hemoptysis). 9) Patients who have undergone or sustained intracranial or spinal surgery or injury within two months prior to obtaining consent. 10) Patients with intracranial tumors, arteriovenous malformations, or aneurysms. 11) Patients under 70 years of age with a prothrombin time-international normalized ratio (PT-INR) of 3.1 or higher, and patients 70 years or older with a PT-INR of 2.7 or higher (except for cases where PT-INR is expected to be lowered to these levels before vitrectomy, considering systemic and intraocular bleeding risks; in such cases, PT-INR must be confirmed to be below 2.7 on the day of surgery). 12) Patients with hypertension whose systolic blood pressure remains 180 mmHg or higher despite antihypertensive treatment. 13) Women of childbearing potential who are not using appropriate contraception, pregnant women, women who may be pregnant, breastfeeding women, or patients planning to become pregnant during the study period. 14) Patients currently participating in another clinical trial or who have participated in another clinical trial within six months prior to obtaining consent. 15) Patients deemed inappropriate for the study by the principal investigator or sub-investigator.