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

NCT ID: NCT03973125

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-28

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Circumscribed Choroidal Haemangioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

conbercept

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Jin Chen-jin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chenjin Jin, Ph.D.

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Kunbei Lai

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kunbei Lai

Role: CONTACT

8602087331366

Chenjin Jin, Ph.D.

Role: CONTACT

Study Principal Investigator

Facility Contacts

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Kunbei Lai

Role: primary

18825135810

Chenjin Jin

Role: backup

13302209900

Other Identifiers

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2018KYPJ082

Identifier Type: -

Identifier Source: org_study_id

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