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

NCT04985448 | Unknown

• 1 other identifier: KH902-ROP-CRP-2.0
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Main effectiveness indicators

  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)

  24 weeks

• Main safety indicators

  The proportion of affected eyes with ocular AEs (within 24 weeks after the first treatment)

  24weeks

• Primary endpoint

  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)

  24 weeks

Secondary Outcomes (12)

• Secondary endpoints

  at 1 week and 24 weeks

• Secondary endpoints

  at 24 weeks

• Secondary endpoints

  within 24 weeks

• Secondary endpoints

  within 24 weeks

• Secondary endpoints

  within 24 weeks

Other Outcomes (4)

• Exploratory Endpoints

  January 1, 2005 to December 31, 2021

• Exploratory Endpoints

  January 1, 2005 to December 31, 2021

• Exploratory Endpoints

  January 1, 2005 to December 31, 2021

Study Arms (3)

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.

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.

Laser Treatment

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Patient who are diagnosed as retinopathy of prematurity using clinical fundus screening;
• 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,;
• Patient for whom the first treatment is laser therapy, intravitreal injection of Conbercept or ranibizumab;

You may not qualify if:

• Patients with neurological diseases that seriously affect visual function;
• Patient or his mother (during pregnancy) has received intravitreal or systemic anti-VEGF drug therapy for other diseases;
• Elimination criteria:
• Patients with insufficient data on treatment or medication;
• Patients who are followed up for less than 3 months after treatment.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead
• Guangzhou Keli Medical Research Co., Ltd.: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jianhong Liang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 2, 2021
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (2)