Actively Recruiting
Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial
Led by Wang Yusheng · Updated on 2025-04-04
146
Participants Needed
3
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the best effective dose and safety of Conbercept, given as an injection, for treating Retinopathy of Prematurity (ROP) in preterm infants. This randomized, double-blind clinical trial compares two low doses of Conbercept to understand which dose works best in managing this eye condition. The study aims to ensure that the treatment stops active ROP and prevents unfavorable eye outcomes by week 24 after treatment starts. Participants will receive an intravitreal injection of Conbercept in both eyes on the first day of treatment. They may receive up to one additional injection in each eye if needed. Two different doses of Conbercept are being compared: 0.25 mg/0.025 mL and 0.15 mg/0.015 mL. The treatment phase is followed by an observational period lasting 24 weeks to monitor the effects and safety of the injections. During the study, infants will be monitored for the absence of active ROP and structural eye problems. Researchers will assess if a single injection was effective, check for any disease reactivation, and observe the development of the peripheral retina’s blood vessels. Safety will be closely watched, and any need for repeated or additional treatments will be recorded. The total participation time includes treatment and observation up to 24 weeks post-treatment.
CONDITIONS
Brief Title
Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants with birth weight of 2000 grams or less or gestational age of 32 weeks or less
- Diagnosed with bilateral type 1 Retinopathy of Prematurity (ROP) with retinal findings including Zone I stage 1+, 2+, 3+/- disease, Zone II stage 2+, 3+ disease, or aggressive ROP (A-ROP)
You will not qualify if you...
- Preterm infants with stage 4 or 5 Retinopathy of Prematurity in one or both eyes
- Previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, or vitrectomy
- Prior exposure to any intravitreal or systemic anti-VEGF agent for the infant or mother during pregnancy
- Use of other investigational drugs (except vitamins or minerals) within 30 days or 5 half-lives before study
- Active eye infection within 5 days before or on the day of first study injection
- History of hypersensitivity to study treatments or similar drugs in the infant or mother
- Any contraindication for intravitreal injection
- Ocular structural abnormalities affecting study assessments
- Other congenital or systemic conditions risking severe visual impact
- Other medical conditions or personal circumstances affecting participation or study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive intravitreal injections of low-dose Conbercept in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required.
Initial injection visit and additional visits if re-treatment is needed
Duration - Up to 24 weeks
Participants are monitored for treatment effectiveness and safety outcomes after the injections.
Regular follow-up visits during the 24-week observational period
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
Research Team
W
Wang
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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