Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases

Study Overview
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Brief Summary
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The purpose of this study is to investigate the role of intravitreal injection of anti-vascular endothelial growth factor (VEGF) therapy in prevention and control of ophthalmological neovascular diseases, in order to find a new strategy of treatment for ophthalmological neovascular diseases

Detailed Description
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Ophthalmological neovascular disease is one of the major causes of blindness in ocular diseases. Up to now, the major treatment strategies include: anti-VEGF therapy, laser therapy and surgery. Clinical treatment have revealed that intravitreal injection of anti-VEGF can effectively restrain neovascularization. Nevertheless, it requires repeated injections, may result in various complications, and may be ineffective in some patients. Therefore, it is necessary to find out other targets which causes retinal neovascularization, in order to find more effective treatments for patients who fail to respond to anti-VEGF therapy. Previous researches have shown that herb monomer (ACM-1) was effective in inhibiting leakage of retinal vessels and neovascularization. So in this study, patients with ophthalmological neovascular diseases will be treated with intravitreal injection of ACM-1, in order to investigate the role of intravitreal injection of ACM-1 therapy in prevention and control of ophthalmological neovascular diseases.

Official Title
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Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases

Conditions
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Neovascularization, Pathologic

Intervention / Treatment
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* Drug: ACM-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age range from 18 to 75 years old without light perception (NLP) A large number of iris or retinal neovascularizations, neovascular glaucoma who needs cyclophotocoagulation or enucleation of eyeball The best corrected visual acuity of the contralateral eye is better than 0.05 Follow-up for more than six months Volunteer for this project and sign the informed consent Exclusion Criteria: The best corrected visual acuity of the contralateral eye is lower than 0.05 Severe systemic disease or other surgical contraindication history of antiangiogenic therapy within one month Ocular neovascularization was caused by other reasons,such as endophthalmitis history of joining in drug clinical trial within one month(except for vitamins and minerals) pre-menopausal women who do not use birth control people are currently being treated for systemic infections Allergic to fluorescein hypertension(SBP is higher than 140mmHg) hepatic renal dysfunction History of drug abuse or alcoholism other situation which will impede the clinical trial, as such depressive disorder the compliance is too poor to finish the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACM-1 team<br>intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml | Drug: ACM-1<br>* intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluorescence fundus angiography |  | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-ocular pressure |  | 6 months after treatment | 
| optical coherence tomography | change in central retinal/lesion thickness (CR/LT) and the mean decrease in thickness at the foveal center > 100 um or >20% center | 6 months after treatment | 
| Retinal Oximetry |  | 6 months after treatment | 
| blood pressure |  | at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment | 
| ocular inflammatory response |  | at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment | 
| morphological changes of the anterior segment |  | at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment | 
| Corneal Endothelium Cell Counter |  | at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment | 
| adverse event |  | at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment | 
| morphological changes of the posterior segment |  | at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACM-1, intravitreal injection, neovascularization