Back to resultsSafety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma
Primary Purpose
Circumscribed Choroidal Haemangioma
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
conbercept
Sponsored by
About this trial
This is an interventional treatment trial for Circumscribed Choroidal Haemangioma focused on measuring conbercept, circumscribed choroidal haemangioma, safety, effectiveness
Eligibility 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.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
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).
Outcomes
Primary Outcome Measures
Best-corrected visual acuity
change of best corrected visual acuity
Secondary Outcome Measures
Central foveal thickness
change of central foveal thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03571282
Brief Title
Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma
Official Title
Safety and Effectiveness Study of Intravitreal Conbercept Injection for Exudative Circumscribed Choroidal Haemangioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Anticipated)
Study Completion Date
June 6, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circumscribed Choroidal Haemangioma
Keywords
conbercept, circumscribed choroidal haemangioma, safety, effectiveness
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
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
conbercept
Other Intervention Name(s)
photodynamic therapy, laser photocoagulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Best-corrected visual acuity
Description
change of best corrected visual acuity
Time Frame
half a year
Secondary Outcome Measure Information:
Title
Central foveal thickness
Description
change of central foveal thickness
Time Frame
half a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kunbei Lai, ph.D.
Phone
8602087331366
Email
laikb@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenjin Jin, Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiawei Wang
Phone
020-87331359
First Name & Middle Initial & Last Name & Degree
Chenjin Jin
Phone
13302209900
First Name & Middle Initial & Last Name & Degree
Chenjin Jin
First Name & Middle Initial & Last Name & Degree
Kunbei Lai
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma
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