Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
NCT ID: NCT06717412
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
146 participants
INTERVENTIONAL
2024-11-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Conbercept
Administered as an intravitreal injection
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
Conbercept
Administered as an intravitreal injection
Interventions
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Conbercept
Administered as an intravitreal injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Wang Yusheng
OTHER
Responsible Party
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Wang Yusheng
Professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY20242291
Identifier Type: -
Identifier Source: org_study_id
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