Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data

NCT ID: NCT04985448

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2022-10-31

Brief Summary

This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease information, clinical treatment status, efficacy evaluation and adverse events and so on will be collected and evaluated by applicability of the data, generated an analysis data set. Use the causal inference method of statistical analysis to observe the effectiveness and safety of intravitreal injection of Conbercept, and explore the effectiveness and safety of different doses in the treatment of retinopathy of prematurity.

Conditions

Retinopathy of Prematurity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Conbercept

In clinical treatment and research, the applied doses of Conbercept in patients with retinopathy of prematurity have been reduced compared with adults, mostly half of the adult dose. The commonly used exposure dose of intravitreal injection of Conbercept ophthalmic injection is 0.25mg/0.025ml.In addition, possible exposure doses are but not limited to 0.15mg/0.15ml, 0.1mg/ 0.1ml, 0.2mg/0.2ml, etc.

No interventions assigned to this group

Ranibizumab

In clinical treatment and research, the applied doses of Ranibizumab in patients with retinopathy of prematurity have been reduced compared with adults, mostly half of the adult dose. The commonly used exposure dose of intravitreal injection of Ranibizumab ophthalmic injection is 0.25mg/0.025ml.In addition, possible exposure doses are but not limited to 0.15mg/0.15ml, 0.1mg/ 0.1ml, 0.2mg/0.2ml, etc.

No interventions assigned to this group

Laser Treatment

In clinical and research studies, lasers are used to treat patients with retinopathy of prematurity.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patient who are diagnosed as retinopathy of prematurity using clinical fundus screening;

2. Patients at the initial stage of treatment whose one eye at least has the following condition: Stage 1+, Stage 2+, Stage 3, Stage 3+ in Zone 1; or Stage 2+, Stage 3+ in Zone 2; or those with AP-ROP according to the international ROP classification,;

3. Patient for whom the first treatment is laser therapy, intravitreal injection of Conbercept or ranibizumab;

Exclusion Criteria

1. Patients with neurological diseases that seriously affect visual function;

2. Patient or his mother (during pregnancy) has received intravitreal or systemic anti-VEGF drug therapy for other diseases;

Elimination criteria:

1. Patients with insufficient data on treatment or medication;

2. Patients who are followed up for less than 3 months after treatment.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Keli Medical Research Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Chengdu Kanghong Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianhong Liang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

KH902-ROP-CRP-2.0

Identifier Type: -

Identifier Source: org_study_id