Back to resultsExploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases
Primary Purpose
Neovascularization, Pathologic
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
ACM-1
Sponsored by
About this trial
This is an interventional treatment trial for Neovascularization, Pathologic focused on measuring ACM-1, intravitreal injection, neovascularization
Eligibility Criteria
Inclusion Criteria:
- age range from 18 to 75 years old
- without light perception (NLP)
- A large number of iris or retinal neovascularizations, neovascular glaucoma who needs cyclophotocoagulation or enucleation of eyeball
- The best corrected visual acuity of the contralateral eye is better than 0.05
- Follow-up for more than six months
- Volunteer for this project and sign the informed consent
Exclusion Criteria:
- The best corrected visual acuity of the contralateral eye is lower than 0.05
- Severe systemic disease or other surgical contraindication
- history of antiangiogenic therapy within one month
- Ocular neovascularization was caused by other reasons,such as endophthalmitis
- history of joining in drug clinical trial within one month(except for vitamins and minerals)
- pre-menopausal women who do not use birth control
- people are currently being treated for systemic infections
- Allergic to fluorescein
- hypertension(SBP is higher than 140mmHg)
- hepatic renal dysfunction
- History of drug abuse or alcoholism
- other situation which will impede the clinical trial, as such depressive disorder
- the compliance is too poor to finish the clinical trial
Sites / Locations
- State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACM-1 team
Arm Description
intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml
Outcomes
Primary Outcome Measures
fluorescence fundus angiography
Secondary Outcome Measures
intra-ocular pressure
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
Retinal Oximetry
blood pressure
ocular inflammatory response
morphological changes of the anterior segment
Corneal Endothelium Cell Counter
adverse event
morphological changes of the posterior segment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02448732
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascularization, Pathologic
Keywords
ACM-1, intravitreal injection, neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACM-1 team
Arm Type
Experimental
Arm Description
intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml
Intervention Type
Drug
Intervention Name(s)
ACM-1
Intervention Description
intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml
Primary Outcome Measure Information:
Title
fluorescence fundus angiography
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
intra-ocular pressure
Time Frame
6 months after treatment
Title
optical coherence tomography
Description
change in central retinal/lesion thickness (CR/LT) and the mean decrease in thickness at the foveal center > 100 um or >20% center
Time Frame
6 months after treatment
Title
Retinal Oximetry
Time Frame
6 months after treatment
Title
blood pressure
Time Frame
at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Title
ocular inflammatory response
Time Frame
at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Title
morphological changes of the anterior segment
Time Frame
at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Title
Corneal Endothelium Cell Counter
Time Frame
at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Title
adverse event
Time Frame
at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Title
morphological changes of the posterior segment
Time Frame
at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age range from 18 to 75 years old
without light perception (NLP)
A large number of iris or retinal neovascularizations, neovascular glaucoma who needs cyclophotocoagulation or enucleation of eyeball
The best corrected visual acuity of the contralateral eye is better than 0.05
Follow-up for more than six months
Volunteer for this project and sign the informed consent
Exclusion Criteria:
The best corrected visual acuity of the contralateral eye is lower than 0.05
Severe systemic disease or other surgical contraindication
history of antiangiogenic therapy within one month
Ocular neovascularization was caused by other reasons,such as endophthalmitis
history of joining in drug clinical trial within one month(except for vitamins and minerals)
pre-menopausal women who do not use birth control
people are currently being treated for systemic infections
Allergic to fluorescein
hypertension(SBP is higher than 140mmHg)
hepatic renal dysfunction
History of drug abuse or alcoholism
other situation which will impede the clinical trial, as such depressive disorder
the compliance is too poor to finish the clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianying Gao, PHD
Phone
13751829105/18922103820
Email
gaoqy@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qianying Gao, PHD
Organizational Affiliation
State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qianying Qao, PFD
Phone
13751829105/18922103820
Email
gaoqy@mail.sysu.edu.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
25890624
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.
Results Reference
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Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases
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