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Tests treatment safety and results for Retinopathy of Prematurity (ROP)
Official title Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
ClinicalTrials.gov ID: NCT06717412
What this study is testing
What is Conbercept?
Conbercept is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for retinopathy of prematurity (rop).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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 how well it works 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...
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
- Xianyang, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China; Xianyang, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.