Conbercept: Administered as an intravitreal injection
Study summary
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of participants with absence of active ROP and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment — Week 24 To achieve this outcome, participants cannot fulfill any of the following criteria:
1. Require intervention for ROP in either eye at or before the week 24 assessment visit with a treatment modality other than Conbercept
2. Have active ROP in either eye at the week 24 assessment visit
3. Have unfavorable structural outcomes (e.g., retinal detachment, retinal traction, macular abnormalities) in either eye at or before week 24 assessment visit
Trial sites (3)
Facility
City
Region
Status
Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
Xi'an
Shaanxi
Recruiting
Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University
Xi'an
Shaanxi
Recruiting
Department of Ophthalmology, Xianyang Rainbow Hospital
Xianyang
Shaanxi
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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