Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03571282
Recruitment Status : Unknown
Verified June 2018 by Jin Chen-jin, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

Condition or disease Intervention/treatment Phase
Circumscribed Choroidal Haemangioma Drug: conbercept Early Phase 1

Detailed Description:
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Study of Intravitreal Conbercept Injection for Exudative Circumscribed Choroidal Haemangioma
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : June 6, 2019
Estimated Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: treatment group
The patients in the treatment group receive three monthly intravitreal injection of conbercept followed by PRN rescue treatments such as intravitreal injection of conbercept, laser photocoagulation (when outside the macular) or photodynamic therapy (when in the macular).
 Drug: conbercept
After three monthly injections of conbercept, if no effects was seen in the patients, the patients will receive rescue treatments such as photodynamic therapy (in the macular) or laser photocoagulation (outside the macular).
Other Names:
  • photodynamic therapy
  • laser photocoagulation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: half a year ]
    change of best corrected visual acuity


Secondary Outcome Measures :
  1. Central foveal thickness [ Time Frame: half a year ]
    change of central foveal thickness


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.

Exclusion Criteria:

  • patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571282


Contacts
Layout table for location contacts
Contact: Kunbei Lai, ph.D. 8602087331366 laikb@163.com

Locations
Layout table for location information
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jiawei Wang    020-87331359      
Contact: Chenjin Jin    13302209900      
Principal Investigator: Chenjin Jin         
Principal Investigator: Kunbei Lai         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Chenjin Jin, Ph.D. Zhongshan Ophthalmic Center, Sun Yat-sen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jin Chen-jin, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03571282    
Other Study ID Numbers: 2018KYPJ081
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jin Chen-jin, Sun Yat-sen University:
conbercept
circumscribed choroidal haemangioma
safety
effectiveness
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms