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Recruiting NCT06717412

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

No phase Interventional Retinopathy of Prematurity (ROP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conbercept.
Who it may be relevant to
Registry conditions: Retinopathy of Prematurity (ROP). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Conbercept
    Administered as an intravitreal injection

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Percentage of participants with effective single intravitreal injection treatment [Time frame: Week 24]
  • Percentage of participants having reactivation at or before week 24 [Time frame: Week 24]
  • Percentage of participants with complete vascularization of the peripheral retina at or before week 24 [Time frame: Week 24]
  • Percentage of participants requiring repeated intervention at or before week 24 [Time frame: Week 24]
  • Percentage of participants requiring interventions with a second modality for ROP at or before week 24 [Time frame: Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 3 centers
  • Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University — Xi'an
  • Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University — Xi'an
  • Department of Ophthalmology, Xianyang Rainbow Hospital — Xianyang

Identifiers

NCT: NCT06717412 · KY20242291

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗