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

Not Applicable

Recruiting

Conditions: Retinopathy of Prematurity (ROP)

Interventions: Drug: Conbercept

Registration Number: NCT06717412

Lead Sponsor: Wang Yusheng

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

Detailed Description: Not available

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 146

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conbercept 0.25 mg/0.025mL	Conbercept	intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required
Conbercept 0.15 mg/0.015mL	Conbercept	intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with effective single intravitreal injection treatment	Week 24	Effective single intravitreal injection treatment is defined as regression of ridge and plus disease after the first study treatment.
Percentage of participants having reactivation at or before week 24	Week 24	Reactivation of ROP is defined as ridge-like change or fibrovascular proliferation occur at the original lesion site, accompanied by the reappearance of plus disease.
Percentage of participants with complete vascularization of the peripheral retina at or before week 24	Week 24	Complete vascularization is defined as participants fulfill any of the following criteria: 1. Fundus photography shows the temporal vessels are less than 2 disc diameter from the ora serrata or the nasal vessels are less than 1 disc diameter from the ora serrata 2. Fluorescein fundus angiography shows the ratio of the distance from the center of the disk to the border of the vascularized zone (DB) and the distance from the center of the disk to the center of the fovea (DF) is greater than 4.0 temporally or greater than 3.3 nasally
Percentage of participants requiring repeated intervention at or before week 24	Week 24	Repeated intervention is defined as receiving other intervention after the first treatment, regardless of the modality.
Percentage of participants requiring interventions with a second modality for ROP at or before week 24	Week 24	Second modality is defined as laser photocoagulation, episcleral buckling, vitrectomy, and anti-VEGF therapy with different type of drug from the first treatment.

Trial Locations

Locations (3): Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
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Xi'an, Shaanxi, China
Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University
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Xi'an, Shaanxi, China
Department of Ophthalmology, Xianyang Rainbow Hospital
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Xianyang, Shaanxi, China