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Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma (IVCCCH)

Primary Purpose

Circumscribed Choroidal Haemangioma

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
conbercept
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Circumscribed Choroidal Haemangioma focused on measuring circumscribed choroidal haemangioma, conbercept, effectiveness, safety

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Kunbei LaiRecruiting

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

First Posted
June 2, 2019
Last Updated
June 2, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03973125
Brief Title
Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma
Acronym
IVCCCH
Official Title
Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma: Short-term Follow-up of Anatomical and Functional Responses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2014 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study was to investigate the safety and effectiveness of application of intravitreal conbercept injection as the primary treatment for exudative circumscribed choroidal haemangioma.
Detailed Description
This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection as the primary treatment 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
circumscribed choroidal haemangioma, conbercept, effectiveness, safety

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
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
12 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
Phone
8602087331366
Email
laikb@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chenjin Jin, Ph.D.
Phone
Study Principal Investigator
Email
jinchj@126.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
Study Chair
Facility Information:
Facility Name
Kunbei Lai
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunbei Lai
Phone
18825135810
Email
laikb@163.com
First Name & Middle Initial & Last Name & Degree
Chenjin Jin
Phone
13302209900
First Name & Middle Initial & Last Name & Degree
Chenjin Jin, ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma

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