NCT03973125

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2014

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2014

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

5.3 years

First QC Date

June 2, 2019

Last Update Submit

June 2, 2019

Conditions

Circumscribed Choroidal Haemangioma

Keywords

circumscribed choroidal haemangiomaconbercepteffectivenesssafety

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

    change of best corrected visual acuity

    half a year

Secondary Outcomes (1)

  • Central foveal thickness

    half a year

Study Arms (1)

Treatment group

EXPERIMENTAL

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).

Drug: conbercept

Interventions

conberceptDRUG

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).

Treatment group

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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.

You may not qualify if:

  • patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kunbei Lai

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

KH902 fusion protein

Study Officials

  • Chenjin Jin, Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Kunbei Lai

CONTACT

8602087331366laikb@163.com

Chenjin Jin, Ph.D.

CONTACT

Study Principal Investigatorjinchj@126.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 4, 2019

Study Start

August 28, 2014

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 4, 2019

Record last verified: 2019-06

Locations

CN(1)