Low-dose Conbercept treatment for Retinopathy of Prematurity
Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial
This study is testing if a low-dose eye treatment called Conbercept can help preterm infants with Retinopathy of Prematurity feel better and improve their vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 3 sites (Xi'an, Shaanxi and 2 other locations) |
| Trial ID | NCT06717412 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of low-dose Conbercept in treating Retinopathy of Prematurity (ROP) in preterm infants. It focuses on determining the optimal effective dose while monitoring for any adverse effects. The study includes infants with specific criteria related to their birth weight and gestational age, and it excludes those with more severe stages of ROP or prior treatments. The goal is to improve outcomes for infants affected by this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants weighing 2000 grams or less at birth or born at 32 weeks of gestation or earlier, with bilateral type 1 ROP.
Not a fit: Patients with stage 4 or 5 ROP or those who have previously received treatment for ROP will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the vision outcomes for preterm infants suffering from Retinopathy of Prematurity.
How similar studies have performed: While there have been studies on ROP treatments, the specific use of low-dose Conbercept represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants with less than or equal to 2000 grams of birth weight or less than or equal to 32 weeks of gestational age * Bilateral type 1 ROP with one of the following retinal findings in each eye * Zone I, stage 1+, 2+, 3+/- disease, or * Zone II, stage 2+, 3+, disease, or * A-ROP Exclusion Criteria: * Preterm infants with stage 4 or 5 ROP in one or both eyes * Have received any previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, vitrectomy * Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy) * Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer * Have active ocular infection within 5 days before or on the day of first investigational treatment * Have a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes * Have any contraindication for intravitreal injection clearly stated in the instructions * Have any ocular structural abnormality that may affect efficacy assessments * Have a history of any other congenital or systemic conditions that are assessed by the investigator to have a significant risk of severe impact on visual function * Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments
Where this trial is running
Xi'an, Shaanxi and 2 other locations
- Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University — Xi'an, Shaanxi, China (Recruiting)
- Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)
- Department of Ophthalmology, Xianyang Rainbow Hospital — Xianyang, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Wang
- Email: wangys003@126.com
- Phone: 02984771794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.