Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma

Circumscribed Choroidal Haemangioma Clinical Trial

Official title:

Safety and Effectiveness Study of Intravitreal Conbercept Injection for Exudative Circumscribed Choroidal Haemangioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571282
• Other study ID #: 2018KYPJ081
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 6, 2018
• Est. completion date: June 6, 2019

Study information

• Verified date: June 2018
• Source: Sun Yat-sen University
• Contact: Kunbei Lai, ph.D.
• Phone: 8602087331366
• Email: laikb[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Circumscribed Choroidal Haemangioma
• Hemangioma

Intervention

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).

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity	change of best corrected visual acuity	half a year
Secondary	Central foveal thickness	change of central foveal thickness	half a year