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Clinical Trials/NCT03571282
NCT03571282
Unknown
Early Phase 1

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

Sun Yat-sen University1 site in 1 country50 target enrollmentJune 6, 2018

Overview

Phase
Early Phase 1
Intervention
conbercept
Conditions
Circumscribed Choroidal Haemangioma
Sponsor
Sun Yat-sen University
Enrollment
50
Locations
1
Primary Endpoint
Best-corrected visual acuity
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2018
End Date
June 6, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Jin Chen-jin

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • 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.

Arms & Interventions

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).

Intervention: conbercept

Outcomes

Primary Outcomes

Best-corrected visual acuity

Time Frame: half a year

change of best corrected visual acuity

Secondary Outcomes

  • Central foveal thickness(half a year)

Study Sites (1)

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