Clinical trial NCT04985448: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinopathy of Prematurity
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Keli Medical Research Co., Ltd.
First posted: 2021-08-02
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with retinopathy of prematurity in treatment of zone 1 (stage 1+, stage 2+, stage 3, stage 3+) or zone 2 (stage 2+, stage 3+) or AP-ROP (rapidly progressive posterior retinopathy of prematurity)

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.


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.

Primary outcomes:
measure: Main effectiveness indicators
timeFrame: 24 weeks
measure: Main safety indicators
timeFrame: 24weeks
measure: Primary endpoint
timeFrame: 24 weeks
Secondary outcomes:
measure: Secondary endpoints
timeFrame: at 1 week and 24 weeks
measure: Secondary endpoints
timeFrame: at 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: at 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
measure: Secondary endpoints
timeFrame: within 24 weeks
Other outcomes:
measure: Exploratory Endpoints
timeFrame: January 1, 2005 to December 31, 2021
measure: Exploratory Endpoints
timeFrame: January 1, 2005 to December 31, 2021
measure: Exploratory Endpoints
timeFrame: January 1, 2005 to December 31, 2021
measure: Exploratory Endpoints
timeFrame: January 1, 2005 to December 31, 2021
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Peking University People's Hospital
name: Jianhong Liang
role: PRINCIPAL_INVESTIGATOR
References: