Actively Recruiting

Phase Not Applicable
All Genders
NCT06717412

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

Led by Wang Yusheng · Updated on 2025-04-04

146

Participants Needed

3

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants with birth weight less than or equal to 2000 grams or gestational age less than or equal to 32 weeks
  • Bilateral type 1 Retinopathy of Prematurity with one of the following retinal findings in each eye: Zone I, stage 1+, 2+, 3+ disease; Zone II, stage 2+, 3+ disease; or Aggressive ROP (A-ROP)
Not Eligible

You will not qualify if you...

  • Preterm infants with stage 4 or 5 Retinopathy of Prematurity in one or both eyes
  • Prior surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, or vitrectomy
  • Previous exposure to any intravitreal or systemic anti-VEGF agent by the patient or mother during pregnancy
  • Use of other investigational drugs (except vitamins and minerals) within 30 days or 5 half-lives of the drug
  • Active eye infection within 5 days before or on the day of first treatment
  • History of hypersensitivity to investigational treatments or similar drugs
  • Contraindication for intravitreal injection
  • Ocular structural abnormalities affecting efficacy assessments
  • Other congenital or systemic conditions posing significant risk to visual function
  • Medical conditions or circumstances affecting study participation or efficacy assessments as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

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

Xi'an, Shaanxi, China, 710032

Actively Recruiting

2

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

Xi'an, Shaanxi, China, 710032

Actively Recruiting

3

Department of Ophthalmology, Xianyang Rainbow Hospital

Xianyang, Shaanxi, China, 712000

Actively Recruiting

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Research Team

W

Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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