Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy

Wang Yusheng

Status: Enrolling

Conditions: Retinopathy of Prematurity (ROP)

Treatments: Drug: Conbercept

Study type: Interventional

Funder types: Other

Identifiers

NCT06717412

KY20242291

Details and patient eligibility

About

Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)

Enrollment: 146 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 2 patient groups

Conbercept 0.25 mg/0.025mL

Active Comparator group

Description:

intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required

Treatment:

Drug: Conbercept

Conbercept 0.15 mg/0.015mL

Experimental group

Description:

intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required

Treatment:

Drug: Conbercept