- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03973125
Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma (IVCCCH)
June 2, 2019 updated by: Jin Chen-jin, Sun Yat-sen University
Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma: Short-term Follow-up of Anatomical and Functional Responses
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kunbei Lai
- Phone Number: 8602087331366
- Email: laikb@163.com
Study Contact Backup
- Name: Chenjin Jin, Ph.D.
- Phone Number: Study Principal Investigator
- Email: jinchj@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Kunbei Lai
-
Contact:
- Chenjin Jin
- Phone Number: 13302209900
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Principal Investigator:
- Chenjin Jin, ph.D.
-
Contact:
- Kunbei Lai
- Phone Number: 18825135810
- Email: laikb@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best-corrected visual acuity
Time Frame: half a year
|
change of best corrected visual acuity
|
half a year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central foveal thickness
Time Frame: half a year
|
change of central foveal thickness
|
half a year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Chenjin Jin, ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2014
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
June 2, 2019
First Submitted That Met QC Criteria
June 2, 2019
First Posted (Actual)
June 4, 2019
Study Record Updates
Last Update Posted (Actual)
June 4, 2019
Last Update Submitted That Met QC Criteria
June 2, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018KYPJ082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Circumscribed Choroidal Haemangioma
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-
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-
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