Retinopathy of Prematurity (ROP)
Conditions
Brief summary
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
Interventions
DRUGConbercept
Administered as an intravitreal injection
Sponsors
Wang Yusheng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with effective single intravitreal injection treatment | Week 24 | Effective single intravitreal injection treatment is defined as regression of ridge and plus disease after the first study treatment. |
| Percentage of participants having reactivation at or before week 24 | 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. |
| Percentage of participants with complete vascularization of the peripheral retina at or before week 24 | 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 |
| Percentage of participants requiring repeated intervention at or before week 24 | Week 24 | Repeated intervention is defined as receiving other intervention after the first treatment, regardless of the modality. |
| Percentage of participants requiring interventions with a second modality for ROP at or before week 24 | 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. |
Countries
China
Contacts
CONTACTWang
Outcome results
None listed