An interventional study of Conbercept in Retinopathy of Prematurity (ROP), sponsored by Wang Yusheng. Recruiting at 3 sites in China. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Wang Yusheng · Not applicable, Interventional, and Treatment
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
Exclusion Criteria:
intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required
Drug: Conbercept
intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required
Drug: Conbercept
Administered as an intravitreal injection
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
To achieve this outcome, participants cannot fulfill any of the following criteria: 1. Require intervention for ROP in either eye at or before the week 24 assessment visit with a treatment modality other than Conbercept 2. Have active ROP in either eye at the week 24 assessment visit 3. Have unfavorable structural outcomes (e.g., retinal detachment, retinal traction, macular abnormalities) in either eye at or before week 24 assessment visit
Time frame: Week 24
Percentage of participants with effective single intravitreal injection treatment
Effective single intravitreal injection treatment is defined as regression of ridge and plus disease after the first study treatment.
Time frame: Week 24
Percentage of participants having reactivation at or before week 24
Reactivation of ROP is defined as ridge-like change or fibrovascular proliferation occur at the original lesion site, accompanied by the reappearance of plus disease.
Time frame: Week 24
Percentage of participants with complete vascularization of the peripheral retina at or before week 24
Complete vascularization is defined as participants fulfill any of the following criteria: 1. Fundus photography shows the temporal vessels are less than 2 disc diameter from the ora serrata or the nasal vessels are less than 1 disc diameter from the ora serrata 2. Fluorescein fundus angiography shows the ratio of the distance from the center of the disk to the border of the vascularized zone (DB) and the distance from the center of the disk to the center of the fovea (DF) is greater than 4.0 temporally or greater than 3.3 nasally
Time frame: Week 24
Percentage of participants requiring repeated intervention at or before week 24
Repeated intervention is defined as receiving other intervention after the first treatment, regardless of the modality.
Time frame: Week 24
Percentage of participants requiring interventions with a second modality for ROP at or before week 24
Second modality is defined as laser photocoagulation, episcleral buckling, vitrectomy, and anti-VEGF therapy with different type of drug from the first treatment.
Time frame: Week 24
VEGF levels in the systemic circulation
Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first treatment, at Day 1, at Week 1 and Week 24.
Time frame: Before the first treatment (Day 0), Day 1, Week 1 and Week 24
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