Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
ConditionRetinopathy of Prematurity (ROP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorWang Yusheng
About this trial
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Conbercept
DrugAdministered as an intravitreal injection
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Conbercept 0.25 mg/0.025mLActive comparator 1 intervention
Group B: Conbercept 0.15 mg/0.015mLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 24Secondary outcomes
1
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 242
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 243
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 244
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 24Other outcomes
1
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 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wang Yusheng
Lead sponsor
Xijing Hospital
Sponsor institution
Source ClinicalTrials.gov