Retinopathy of Prematurity (ROP)NCT06717412
Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
A study testing Conbercept in people with Retinopathy of Prematurity (ROP), run by Wang Yusheng at 3 sites in China.
Trial summary
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- Conbercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesChina
- Study dates
- 29 Nov 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, 710032
He, 02984771273, openji7127@hotmail.com
- Recruiting
Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University
Xi'an, Shaanxi, 710032
Wang, 02984771273, wangys003@126.com
- Recruiting
Department of Ophthalmology, Xianyang Rainbow Hospital
Xianyang, Shaanxi, 712000
Xue, 02984771273, 1915992512@qq.com
About this study
Official title: Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- Conbercept
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConberceptDrug
Administered as an intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Conbercept 0.25 mg/0.025mL | Active comparator | intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required Receives: Drug: Conbercept |
| Conbercept 0.15 mg/0.015mL | Experimental | intravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required Receives: Drug: Conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Require intervention for ROP in either eye at or before the week 24 assessment visit with a treatment modality other than Conbercept
- Have active ROP in either eye at the week 24 assessment visit
- Have unfavorable structural outcomes (e.g., retinal detachment, retinal traction, macular abnormalities) in either eye at or before week 24 assessment visit
Measured: Week 24
Secondary outcomes (5)
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.
Measured: Week 24
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.
Measured: Week 24
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:
- 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
- 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
Measured: Week 24
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.
Measured: Week 24
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start29 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Yusheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Yusheng, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717412
- Sponsor's protocol ID
- KY20242291
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06717412
- Acronym / sponsor ID
- KY20242291
- Conditions
- Retinopathy of Prematurity (ROP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Wang YushengUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conbercept 0.25 mg/0.025mL | Active comparator | Drug: Conberceptintravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required |
| Conbercept 0.15 mg/0.015mL | Experimental | Drug: Conberceptintravitreal injection in both eyes on Day 0, with up to 1 re-treatment allowed for each eye if required |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConberceptAdministered as an intravitreal injection | Drug | Conbercept 0.15 mg/0.015mL, Conbercept 0.25 mg/0.025mL |
Primary outcome
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
Time frame: 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
5 secondary outcomes
Percentage of participants with effective single intravitreal injection treatment
Time frame: Week 24
Percentage of participants having reactivation at or before week 24
Time frame: Week 24
Percentage of participants with complete vascularization of the peripheral retina at or before week 24
Time frame: Week 24
Percentage of participants requiring repeated intervention at or before week 24
Time frame: Week 24
Percentage of participants requiring interventions with a second modality for ROP at or before week 24
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conbercept in people with Retinopathy of Prematurity (ROP), run by Wang Yusheng at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang (02984771794, wangys003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.