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Clinical Trials/NCT06717412
NCT06717412RecruitingNot Applicable

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

Wang Yusheng3 sites in 1 country146 target enrollmentStarted: November 29, 2024Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
146
Locations
3
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts 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

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

Arms & Interventions

Conbercept 0.15 mg/0.015mL

Experimental

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

Intervention: Conbercept (Drug)

Conbercept 0.25 mg/0.025mL

Active Comparator

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

Intervention: Conbercept (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Percentage of participants with effective single intravitreal injection treatment(Week 24)
  • Percentage of participants having reactivation at or before week 24(Week 24)
  • Percentage of participants with complete vascularization of the peripheral retina at or before week 24(Week 24)
  • Percentage of participants requiring repeated intervention at or before week 24(Week 24)
  • Percentage of participants requiring interventions with a second modality for ROP at or before week 24(Week 24)

Investigators

Sponsor
Wang Yusheng
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Wang Yusheng

Professor

Xijing Hospital

Study Sites (3)

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Efficacy and Safety of Low-dose Conbercept... | Clinical Trial