Clinical trial NCT06717412: Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
Official title: Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinopathy of Prematurity (ROP)
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of participants with effective single intravitreal injection treatment
timeFrame: Week 24
measure: Percentage of participants having reactivation at or before week 24
timeFrame: Week 24
measure: Percentage of participants with complete vascularization of the peripheral retina at or before week 24
timeFrame: Week 24
measure: Percentage of participants requiring repeated intervention at or before week 24
timeFrame: Week 24
measure: Percentage of participants requiring interventions with a second modality for ROP at or before week 24
timeFrame: Week 24
Other outcomes:
measure: VEGF levels in the systemic circulation
timeFrame: Before the first treatment (Day 0), Day 1, Week 1 and Week 24
Locations:
city: Xi'an
country: China
facility: Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University
state: Shaanxi
city: Xianyang
country: China
facility: Department of Ophthalmology, Xianyang Rainbow Hospital
state: Shaanxi
Study officials:
References: