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

NCT ID: NCT02448732

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Neovascularization, Pathologic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACM-1 team

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

Group Type: EXPERIMENTAL

ACM-1

Intervention Type: DRUG

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

Interventions

ACM-1

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qianying Gao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qianying Gao, PHD

Role: PRINCIPAL_INVESTIGATOR

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qianying Gao, PHD

Role: CONTACT

gaoqy@mail.sysu.edu.cn

13751829105/18922103820

Facility Contacts

Qianying Qao, PFD

Role: primary

gaoqy@mail.sysu.edu.cn

13751829105/18922103820

References

Adatia FA, Luong M, Munro M, Tufail A. The other CNVM: a review of myopic choroidal neovascularization treatment in the age of anti-vascular endothelial growth factor agents. Surv Ophthalmol. 2015 May-Jun;60(3):204-15. doi: 10.1016/j.survophthal.2014.10.002. Epub 2014 Nov 5.

Reference Type: BACKGROUND

PMID: 25890624 (View on PubMed)

Other Identifiers

Sun Yat-sen Un

Identifier Type: -

Identifier Source: org_study_id