Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma

Early Phase 1

• Conditions: Circumscribed Choroidal Haemangioma
• Interventions: Drug: conbercept

• Registration Number: NCT03571282
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-06-06
• Study First Submitted: 2018-06-16
• Study First Submitted QC: 2018-06-16
• Last Update Submitted: 2018-06-16
• Study First Posted: 2018-06-27
• Last Update Posted: 2018-06-27
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	conbercept	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).

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity	half a year	change of best corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
Central foveal thickness	half a year	change of central foveal thickness

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China