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

• Conditions: Retinopathy of Prematurity

• Registration Number: NCT04985448
• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-08-02
• Status Verified: 2022-09
• Study Start: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main effectiveness indicators	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	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	24weeks	The proportion of affected eyes with ocular AEs (within 24 weeks after the first treatment)

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints	within 24 weeks	To evaluate the proportion of eyes with ROP complications within 24 weeks after the first treatment. (Complications include cataracts, glaucoma, vitreous hemorrhage, retinal detachment, fibrosis, and ocular atrophy, etc.)

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China