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Research on Screening and Prediction of Long-term Efficacy of Anti-VEGF Therapy in Retinopathy of Prematurity Based on Mass Spectrometry

Research on Screening and Prediction of Long-term Efficacy of Anti-VEGF Therapy in Retinopathy of Prematurity Based on Mass Spectrometry

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300079072
Enrollment
Unknown
Registered
2023-12-25
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of prematurity

Interventions

the ROP group (Part 1):ROP
the control group (Part 1):non-ROP but with prematurity
Children with ROP who received intravitreal injection of anti-VEGF drugs (Part 2):intravitreal injection of anti-VEGF drugs

Sponsors

Shenzhen Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: 1: Part 1: the ROP group: a. Gender unlimited, corrected gestational age at sampling = 45 weeks; b. Children who meet the diagnosis of ROP (based on the International Classification of ROP (3rd edition)); c. Voluntarily participate in this study, with the child's guardian signing an informed consent form, and the samples kept in the biobank. 2: Part 1: the control group: a. Children whose gender, corrected gestational age at sampling, birth gestational age, and birth weight are matched with the ROP group (Gender is precise matched, with a matching range of corrected gestational age and birth gestational age that does not differ by more than 1 week, and a matching range of birth weight that does not differ by more than 200g); b. Voluntarily participate in this study, with the child's guardian signing an informed consent form, and the samples kept in the biobank. 3. Part 2: Participants (Children with ROP who received intravitreal injection of anti-VEGF drugs): a. Gender unlimited. At the initial sampling, the corrected gestational age was = 45 weeks and biological samples were retained in the early morning before surgery on the day of intravitreal injection of anti-VEGF drugs; b. Children who meet the diagnosis of ROP (based on the International Classification of ROP (3rd edition)) and receive intravitreal injection of anti-VEGF drugs and complete the follow-up process; c. Voluntarily participate in this study, with the child's guardian signing an informed consent form, and the samples kept in the biobank.

Exclusion criteria

Exclusion criteria: 1: Part 1: the ROP group: a. Non-ROP children; b. Children with other eye diseases (except congenital cataracts), such as morning glory syndrome; c. Individuals with a history of previous surgery or trauma; d. The sample is not qualified; e. Researchers believe that it is not suitable. 2: Part 1: the control group: a. Children with ROP; b. Children with eye diseases (except congenital cataracts), such as FEVR, Coats disease, morning glory syndrome, etc; c. Patients with retinal detachment or retinal neovascularization caused by various reasons within one year after sample collection; d. The sample is not qualified; e. Researchers believe that it is not suitable. 3: Part 2: Participants (Children with ROP who received intravitreal injection of anti-VEGF drugs): a. Non-ROP children; b. Children with ROP who didn't undergo intravitreal injection of anti VEGF drugs; c. Children with ROP who received intravitreal injection of anti-VEGF drugs but did not complete the follow-up process; d. Children with other eye diseases (except congenital cataracts), such as morning glory syndrome; e. Individuals with a history of trauma; f. Patients with other diseases that affect the results during the follow-up process; g. The sample is not qualified; h. Researchers believe that it is not suitable.

Design outcomes

Primary

MeasureTime frame
proteomics;metabolomics;

Secondary

MeasureTime frame
efficacy of anti-VEGF therapy;

Countries

China

Contacts

Public ContactZixin Fan

Shenzhen Eye Hospital

260909903@qq.com+86 188 1943 0526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026