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

Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Retinopathy of Prematurity (ROP)
• Intervention / Treatment: Drug: Conbercept

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang; Phone Number: 02984771794; Email: wangys003@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
      • Contact: He; Phone Number: 02984771273; Email: openji7127@hotmail.com
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University
      • Contact: Wang; Phone Number: 02984771273; Email: wangys003@126.com
    • Xianyang, Shaanxi, China, 712000
      • Recruiting
      • Department of Ophthalmology, Xianyang Rainbow Hospital
      • Contact: Xue; Phone Number: 02984771273; Email: 1915992512@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conbercept 0.25 mg/0.025mL; intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required	Drug: Conbercept; Administered as an intravitreal injection
Experimental: Conbercept 0.15 mg/0.015mL; intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required	Drug: Conbercept; Administered as an intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To achieve this outcome, participants cannot fulfill any of the following criteria: Require intervention for ROP in either eye at or before the week 24 assessment visit with a treatment modality other than Conbercept; Have active ROP in either eye at the week 24 assessment visit; Have unfavorable structural outcomes (e.g., retinal detachment, retinal traction, macular abnormalities) in either eye at or before week 24 assessment visit	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with effective single intravitreal injection treatment	Effective single intravitreal injection treatment is defined as regression of ridge and plus disease after the first study treatment.	Week 24
Percentage of participants having reactivation at or before 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.	Week 24
Percentage of participants with complete vascularization of the peripheral retina at or before week 24	Complete vascularization is defined as participants fulfill any of the following criteria: 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; 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	Week 24
Percentage of participants requiring repeated intervention at or before week 24	Repeated intervention is defined as receiving other intervention after the first treatment, regardless of the modality.	Week 24
Percentage of participants requiring interventions with a second modality for ROP at or before 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.	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VEGF levels in the systemic circulation	Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first treatment, at Day 1, at Week 1 and Week 24.	Before the first treatment (Day 0), Day 1, Week 1 and Week 24

Collaborators and Investigators

• Sponsor: Wang Yusheng

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Infant, Premature, Diseases; Infant, Newborn, Diseases; Eye Diseases; Premature Birth; Retinal Diseases; Retinopathy of Prematurity
• Other Study ID Numbers: KY20242291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No