Neovascularization, PathologicEarly Phase 1NCT02448732
Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases
A Early Phase 1 study testing ACM-1 in people with Neovascularization, Pathologic, run by Sun Yat-sen University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neovascularization, Pathologic
- What is being tested?
- ACM-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Jun 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Qianying Qao, PFD, 13751829105/18922103820, gaoqy@mail.sysu.edu.cn
About this study
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
Read the 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
- Being tested
- ACM-1
- Keywords
- ACM-1, intravitreal injection, neovascularization
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACM-1Drug
intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml
| Study group | Role | What they receive |
|---|---|---|
| ACM-1 team | Experimental | intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml Receives: Drug: ACM-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluorescence fundus angiography
Measured: 6 months after treatment
Secondary outcomes (9)
intra-ocular pressure
Measured: 6 months after treatment
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
Measured: 6 months after treatment
Retinal Oximetry
Measured: 6 months after treatment
blood pressure
Measured: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
ocular inflammatory response
Measured: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
morphological changes of the anterior segment
Measured: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Corneal Endothelium Cell Counter
Measured: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
adverse event
Measured: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
morphological changes of the posterior segment
Measured: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascularization, PathologicStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qianying Gao, Sun Yat-sen University
- Investigators
- Qianying Gao, PHD, Principal investigator, State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448732
- Sponsor's protocol ID
- Sun Yat-sen Un
- Status last verified
- May 2015
- First submitted
- 15 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25890624
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Trials of ACM-1 in the Treatment of Ophthalmological Neovascular Diseases
- ClinicalTrials.gov ID
- NCT02448732
- Acronym / sponsor ID
- Sun Yat-sen Un
- Conditions
- Neovascularization, Pathologic
- Keywords
- ACM-1, intravitreal injection, neovascularization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACM-1 team | Experimental | Drug: ACM-1intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACM-1intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml | Drug | ACM-1 team |
Primary outcome
fluorescence fundus angiography
Time frame: 6 months after treatment
9 secondary outcomes
intra-ocular pressure
Time frame: 6 months after treatment
optical coherence tomography
Time frame: 6 months after treatment
Retinal Oximetry
Time frame: 6 months after treatment
blood pressure
Time frame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
ocular inflammatory response
Time frame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
morphological changes of the anterior segment
Time frame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Corneal Endothelium Cell Counter
Time frame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
adverse event
Time frame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
morphological changes of the posterior segment
Time frame: at admission, 1 day ,3days,1 week, 1month ,3moths and 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Background: PubMed 25890624Adatia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qianying Gao, PHD principal investigator
State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ACM-1 in people with Neovascularization, Pathologic, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianying Gao, PHD (13751829105/18922103820, gaoqy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluorescence fundus angiography (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.