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

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

Study Overview

• Status: Unknown
• Conditions: Neovascularization, Pathologic
• Intervention / Treatment: Drug: ACM-1

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Qianying Qao, PFD; Phone Number: 13751829105/18922103820; Email: gaoqy@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACM-1 team; intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml	Drug: ACM-1; intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fluorescence fundus angiography	6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra-ocular pressure		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	6 months after treatment
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
morphological changes of the anterior segment		at admission, 1 day ,3days,1 week, 1month ,3moths and 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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: May 15, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: intravitreal injection; neovascularization; ACM-1
• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Neovascularization, Pathologic
• Other Study ID Numbers: Sun Yat-sen Un