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

Early Phase 1

• Conditions: Neovascularization, Pathologic
• Interventions: Drug: ACM-1

• Registration Number: NCT02448732
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-05
• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-19
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20
• Primary Completion: 2016-04
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. age range from 18 to 75 years old
2. without light perception (NLP)
3. A large number of iris or retinal neovascularizations, neovascular glaucoma who needs cyclophotocoagulation or enucleation of eyeball
4. The best corrected visual acuity of the contralateral eye is better than 0.05
5. Follow-up for more than six months
6. Volunteer for this project and sign the informed consent

Exclusion Criteria

1. The best corrected visual acuity of the contralateral eye is lower than 0.05
2. Severe systemic disease or other surgical contraindication
3. history of antiangiogenic therapy within one month
4. Ocular neovascularization was caused by other reasons,such as endophthalmitis
5. history of joining in drug clinical trial within one month(except for vitamins and minerals)
6. pre-menopausal women who do not use birth control
7. people are currently being treated for systemic infections
8. Allergic to fluorescein
9. hypertension(SBP is higher than 140mmHg)
10. hepatic renal dysfunction
11. History of drug abuse or alcoholism
12. other situation which will impede the clinical trial, as such depressive disorder
13. the compliance is too poor to finish the clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACM-1 team	ACM-1	intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml

Primary Outcome Measures

Name	Time	Method
fluorescence fundus angiography	6 months after treatment

Secondary Outcome Measures

Name	Time	Method
Retinal Oximetry	6 months after treatment
intra-ocular pressure	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
optical coherence tomography	6 months after treatment	change in central retinal/lesion thickness (CR/LT) and the mean decrease in thickness at the foveal center \> 100 um or \>20% center
Corneal Endothelium Cell Counter	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
blood pressure	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

Trial Locations

Locations (1)

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China