RecruitingNot ApplicableNCT06717412

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


Sponsor

Wang Yusheng

Enrollment

146 participants

Start Date

Nov 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Inclusion Criteria5

  • 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 Criteria10

  • 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

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Interventions

DRUGConbercept

Administered as an intravitreal injection


Locations(3)

Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, China

Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University

Xi'an, Shaanxi, China

Department of Ophthalmology, Xianyang Rainbow Hospital

Xianyang, Shaanxi, China

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NCT06717412


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