Retinopathy of Prematurity
Conditions
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.
Interventions
None listed
Sponsors
Guangzhou Keli Medical Research Co., Ltd.
Chengdu Kanghong Biotech Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Main safety indicators | 24weeks | The proportion of affected eyes with ocular AEs (within 24 weeks after the first 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoints | at 1 week and 24 weeks | To evaluate the response rate of the first treatment at 1 week and 24 weeks after the first treatment (the response rate is defined as the proportion of patients after the first treatment who do not need the second treatment, with disappearance of the additional lesions or the reduction of the vascular tortuosity, the reduction or regression of the ridges, and with initiation of vascularization in the neighboring avas-cular area (or retinal vascularization to zone III); |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Endpoints | January 1, 2005 to December 31, 2021 | To explore and evaluate the changes in the following longterm observational indicators, which are for descriptive analysis only. 1、Proportion of target eyes with complete retinal vascularization (the complete retinal vascularization is defined as retinal blood vessels extending to the serrata on the nasal side, and 1 optic disc diameter from the serrata on the temporal side); |
Countries
China
Outcome results
None listed