Low-dose Conbercept treatment for Retinopathy of Prematurity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imaging retinal structure in premature babies to guide care

  This study tests whether bedside ultra-widefield eye imaging can better guide treatment decisions for retinopathy of prematurity in preterm infants.

  Recruiting Duke University · Durham, North Carolina and 1 other locations · NCT07738874

• Does early red blood cell transfusion affect complications and neurodevelopment in premature infants?

  This study tests whether giving blood transfusions in the first month of life in premature babies is linked to early complications like ROP, NEC, BPD, IVH, and to later neurodevelopmental outcomes.

  Recruiting Clinical Hospital Center Rijeka · Rijeka, Primorje-Gorski Kotar County · NCT07123948

• Testing FLQ-101 for retinopathy of prematurity in very premature newborns

  This will test whether giving FLQ-101 to very premature babies (born at 26+0 to 27+6 weeks and weighing ≥650 g) is safe and produces the expected drug effects in their bodies.

  Recruiting Phase 1 Feliqs INC. · Austin, Texas · NCT07093255

• Evaluating pain relief methods during eye exams for premature infants

  This study is testing two different ways to hold premature infants during eye exams to see which one helps reduce their pain better.

  Recruiting Ege University · Izmir, Menemen · NCT06694103

• New imaging technology for diagnosing retinopathy of prematurity in infants

  This study is testing a new imaging technology to help doctors better see and understand eye problems in premature infants with retinopathy of prematurity.

  Recruiting Vanderbilt University Medical Center · Nashville, Tennessee · NCT06612541

• Incidence of hypoxia during intravitreal ranibizumab injections for retinopathy of prematurity under topical anesthesia

  This study looks at how often and how severely babies with retinopathy of prematurity experience low oxygen levels during bedside eye injections with topical anesthesia.

  Recruiting Minia University · Buraidah · NCT07701759

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.