Clinical trial NCT02448732: Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases
Official title: Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Neovascularization, Pathologic
Keywords: ACM-1
intravitreal injection
neovascularization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: fluorescence fundus angiography
timeFrame: 6 months after treatment
Secondary outcomes:
measure: intra-ocular pressure
timeFrame: 6 months after treatment
measure: optical coherence tomography
timeFrame: 6 months after treatment
measure: Retinal Oximetry
timeFrame: 6 months after treatment
measure: blood pressure
timeFrame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
measure: ocular inflammatory response
timeFrame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
measure: morphological changes of the anterior segment
timeFrame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
measure: Corneal Endothelium Cell Counter
timeFrame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
measure: adverse event
timeFrame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
measure: morphological changes of the posterior segment
timeFrame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Qianying Gao, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.