Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
Administered as an intravitreal injection
Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, China
RECRUITINGDepartment of Ophthalmology, Xijing Hospital, Air Force Military Medical University
Xi'an, Shaanxi, China
RECRUITINGDepartment of Ophthalmology, Xianyang Rainbow Hospital
Xianyang, Shaanxi, China
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
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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