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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinopathy of Prematurity
- Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Enrollment
- 1000
- Locations
- 2
- Primary Endpoint
- Main effectiveness indicators
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Main effectiveness indicators
Time Frame: 24 weeks
Proportion of eyes with no active retinopathy of prematurity and no structural adverse outcome (within 24 weeks after the first treatment; active retinopathy of prematurity is defined as additional lesions, vascular tortuosity, crest and other lesions having no alleviation but trend of progress after clinical treatment and new blood vessels continuing to exist or new born; poor structural outcomes are defined as adverse results such as retinal detachment, retinal traction or macular abnormalities after clinical treatment)
Primary endpoint
Time Frame: 24 weeks
To evaluate the proportion of eyes with inactive retinopathy of prematurity and without structural adverse outcomes at 24 weeks after the first treatment (inactive retinopathy of prematurity is defined as the reduction in additional lesions, vascular tortuosity, ridges and other lesions after clinical treatment, showing no trend of progression, no persistent or newly developed neovascularization; no structural adverse outcome is defined as the absence of adverse outcomes such as retinal detachment, retinal traction, or macular abnormalities after clinical treatment)
Main safety indicators
Time Frame: 24weeks
The proportion of affected eyes with ocular AEs (within 24 weeks after the first treatment)
Secondary Outcomes
- Secondary endpoints(within 24 weeks)