Neovascularization, Pathologic
Conditions
Keywords
ACM-1, intravitreal injection, neovascularization
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.
Interventions
DRUGACM-1
intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fluorescence fundus angiography | 6 months after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| intra-ocular pressure | 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 | — |
| morphological changes of the anterior segment | at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment | — |
Countries
China
Contacts
Primary ContactQianying Gao, PHD
Outcome results
None listed