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RecruitingNCT06717412Updated Jul 30, 2026

Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy

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

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Sex
All
01

Study summary

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

02

Conditions studied

  • Retinopathy of Prematurity (ROP)
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
146 participants (estimated)

Study arms

  • Active comparator
    Conbercept 0.25 mg/0.025mL

    intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required

    Drug: Conbercept

  • Experimental
    Conbercept 0.15 mg/0.015mL

    intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required

    Drug: Conbercept

Interventions

  • DrugConbercept

    Administered as an intravitreal injection

05

What researchers measure

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 24

Secondary 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 24

  2. 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

  3. 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

  4. 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

  5. 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

Other 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 24

06

Study locations

3 of 3 sites recruiting
  • Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
    Xi'an, Shaanxi 710032, China
    Recruiting
  • Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University
    Xi'an, Shaanxi 710032, China
    Recruiting
  • Department of Ophthalmology, Xianyang Rainbow Hospital
    Xianyang, Shaanxi 712000, China
    Recruiting
07

Registry details

Key details

Study ID
NCT06717412
Lead sponsor
Wang Yusheng
Responsible party
Wang Yusheng (Professor, Xijing Hospital) — Sponsor-investigator
First posted
Dec 5, 2024
Start date
Nov 29, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Jul 30, 2026

Study contacts

Wang
Contact
wangys003@126.com
02984771794

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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