ClinicalTrials.gg
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

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.

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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

In context

Retinopathy of Prematurity

169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.

This study's planned enrollment of 146 is above the median of 82 across 102 interventional studies indexed under Retinopathy of Prematurity.

Browse Retinopathy of Prematurity studies →

Lead sponsor

This is the only study on the registry with Wang Yusheng as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
  • Have any 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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

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

  • Administered as an intravitreal injection

06

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

07

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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.

Of 28 non-industry interventional studies with no phase under Retinopathy of Prematurity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 25 months is above that.

Counting every sponsor, half of 30 studies reached it within 14 months; a quarter within 11 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2024
First posted
Dec 5, 2024
StartActual
Nov 29, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jan 31, 2028
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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