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

Neovascularization, Pathologic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448732
• Other study ID #: Sun Yat-sen Un
• Status: Recruiting
• Phase: Phase 0
• First received: May 15, 2015
• Last updated: May 19, 2015
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: Qianying Gao, PHD
• Phone: 13751829105/18922103820
• Email: gaoqy[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
China	State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluorescence fundus angiography		6 months after treatment	No
Secondary	intra-ocular pressure		6 months after treatment	No
Secondary	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	No
Secondary	Retinal Oximetry		6 months after treatment	No
Secondary	blood pressure		at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment	Yes
Secondary	ocular inflammatory response		at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment	Yes
Secondary	morphological changes of the anterior segment		at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment	Yes
Secondary	Corneal Endothelium Cell Counter		at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment	Yes
Secondary	adverse event		at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment	Yes
Secondary	morphological changes of the posterior segment		at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment	Yes