NCT02448732

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

May 15, 2015

Last Update Submit

May 19, 2015

Conditions

Neovascularization, Pathologic

Keywords

ACM-1intravitreal injectionneovascularization

Outcome Measures

Primary Outcomes (1)

  • fluorescence fundus angiography

    6 months after treatment

Secondary Outcomes (9)

  • intra-ocular pressure

    6 months after treatment

  • optical coherence tomography

    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

  • +4 more secondary outcomes

Study Arms (1)

ACM-1 team

EXPERIMENTAL

intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml

Drug: ACM-1

Interventions

ACM-1DRUG

intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml

ACM-1 team

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25890624BACKGROUND

MeSH Terms

Conditions

Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

MetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qianying Gao, PHD

    State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianying Gao, PHD

CONTACT

13751829105/18922103820gaoqy@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

December 1, 2014

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CN(1)