Retinopathy of PrematurityNCT04985448
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
An observational study of Retinopathy of Prematurity, run by Chengdu Kanghong Biotech Co., Ltd. at 2 sites in China.
Trial summary
This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease information, clinical treatment status, efficacy evaluation and adverse events and so on will be… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2022to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The patients with retinopathy of prematurity in treatment of zone 1 (stage 1+, stage 2+, stage 3, stage 3+) or zone 2 (stage 2+, stage 3+) or AP-ROP (rapidly progressive posterior retinopathy of prematurity)
Who may be able to join
- Patient who are diagnosed as retinopathy of prematurity using clinical fundus screening;
- Patients at the initial stage of treatment whose one eye at least has the following condition: Stage 1+, Stage 2+, Stage 3, Stage 3+ in Zone 1; or Stage 2+, Stage 3+ in Zone 2; or those with AP-ROP according to the international ROP classification,;
- Patient for whom the first treatment is laser therapy, intravitreal injection of Conbercept or ranibizumab;
Who cannot join
- Patients with neurological diseases that seriously affect visual function;
- Patient or his mother (during pregnancy) has received intravitreal or systemic anti-VEGF drug therapy for other diseases;
- Elimination criteria:
- Patients with insufficient data on treatment or medication;
- Patients who are followed up for less than 3 months after treatment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University People's Hospital
Beijing, Beijing Municipality
West China Hospital of Sichuan University
Chengdu, Sichuan
About this study
This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease information, clinical treatment status, efficacy evaluation and adverse events and so on will be collected and evaluated by applicability of the data, generated an analysis data set. Use the causal inference method of statistical analysis to observe the effectiveness and safety of intravitreal injection of Conbercept, and explore the effectiveness and safety of different doses in the treatment of retinopathy of prematurity.
- Conditions
- Retinopathy of Prematurity
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Conbercept | In clinical treatment and research, the applied doses of Conbercept in patients with retinopathy of prematurity have been reduced compared with adults, mostly half of the adult dose. The commonly used exposure dose of intravitreal injection of Conbercept ophthalmic injection is 0.25mg/0.025ml.In addition, possible exposure doses are but not limited to 0.15mg/0.15ml, 0.1mg/ 0.1ml, 0.2mg/0.2ml, etc. | |
| Ranibizumab | In clinical treatment and research, the applied doses of Ranibizumab in patients with retinopathy of prematurity have been reduced compared with adults, mostly half of the adult dose. The commonly used exposure dose of intravitreal injection of Ranibizumab ophthalmic injection is 0.25mg/0.025ml.In addition, possible exposure doses are but not limited to 0.15mg/0.15ml, 0.1mg/ 0.1ml, 0.2mg/0.2ml, etc. | |
| Laser Treatment | In clinical and research studies, lasers are used to treat patients with retinopathy of prematurity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main effectiveness indicators
Proportion of eyes with no active retinopathy of prematurity and no structural adverse outcome (within 24 weeks after the first treatment; active retinopathy of prematurity is defined as additional lesions, vascular tortuosity, crest and other lesions having no alleviation but trend of progress after clinical treatment and new blood vessels continuing to exist or new born; poor structural outcomes are defined as adverse results such as retinal detachment, retinal traction or macular abnormalities after clinical treatment)
Measured: 24 weeks
Main safety indicators
The proportion of affected eyes with ocular AEs (within 24 weeks after the first treatment)
Measured: 24weeks
Primary endpoint
To evaluate the proportion of eyes with inactive retinopathy of prematurity and without structural adverse outcomes at 24 weeks after the first treatment (inactive retinopathy of prematurity is defined as the reduction in additional lesions, vascular tortuosity, ridges and other lesions after clinical treatment, showing no trend of progression, no persistent or newly developed neovascularization; no structural adverse outcome is defined as the absence of adverse outcomes such as retinal detachment, retinal traction, or macular abnormalities after clinical treatment)
Measured: 24 weeks
Secondary outcomes (12)
Secondary endpoints
To evaluate the response rate of the first treatment at 1 week and 24 weeks after the first treatment (the response rate is defined as the proportion of patients after the first treatment who do not need the second treatment, with disappearance of the additional lesions or the reduction of the vascular tortuosity, the reduction or regression of the ridges, and with initiation of vascularization in the neighboring avas-cular area (or retinal vascularization to zone III);
Measured: at 1 week and 24 weeks
Secondary endpoints
To evaluate the proportion of eyes with recurrence and the time to recurrence at 24 weeks after the first treatment (recurrence is defined as the recurrence of ridgelike changes or fibrovascular proliferation in the original lesion, complicated by the recurrence of additional lesions in the posterior pole);
Measured: at 24 weeks
Secondary endpoints
To evaluate the proportion of eyes undergoing the second treatment within 24 weeks after the first treatment (the second treatment is defined as the second treatment that is given after the first treatment, regardless of whether the treatment measure is adjusted or not);
Measured: within 24 weeks
Secondary endpoints
To evaluate the proportion of target eyes requiring a second treatment modality within 24 weeks after the first treatment (the treatment modality means laser therapy, anti-VEGF drug therapy and surgery, and the second treatment modality includes change of anti-VEGF drug);
Measured: within 24 weeks
Secondary endpoints
To evaluate the proportion of target eyes whose treatment measures were switched within 24 weeks after the first treatment (the switching treatment is defined as the conversion to laser therapy, anti-VEGF drug therapy and surgery);
Measured: within 24 weeks
Secondary endpoints
To evaluate the number of treatments with Conbercept, ranibizumab, and laser within 24 weeks after the first treatment;
Measured: within 24 weeks
Secondary endpoints
To evaluate the proportion of eyes with ocular AEs within 24 weeks after the first treatment;
Measured: within 24 weeks
Secondary endpoints
To evaluate the proportion of eyes with TEAEs within 24 weeks after the first treatment;
Measured: within 24 weeks
Secondary endpoints
To evaluate the proportion of eyes with aggravated retinopathy staging at 24 weeks after the first treatment;
Measured: at 24 weeks
Secondary endpoints
To evaluate the incidence of endophthalmitis within 24 weeks after the first treatment;
Measured: within 24 weeks
Secondary endpoints
To evaluate the proportion of eyes undergoing vitreous surgery within 24 weeks after the first treatment;
Measured: within 24 weeks
Secondary endpoints
To evaluate the proportion of eyes with ROP complications within 24 weeks after the first treatment. (Complications include cataracts, glaucoma, vitreous hemorrhage, retinal detachment, fibrosis, and ocular atrophy, etc.)
Measured: within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study startSep 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Keli Medical Research Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jianhong Liang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985448
- Sponsor's protocol ID
- KH902-ROP-CRP-2.0
- Status last verified
- Sep 2022
- First submitted
- 23 Jul 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
- ClinicalTrials.gov ID
- NCT04985448
- Acronym / sponsor ID
- KH902-ROP-CRP-2.0
- Conditions
- Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Keli Medical Research Co., Ltd.
- Study start
- Sep 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 2 Aug 2021 (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.
This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease information, clinical treatment status, efficacy evaluation and adverse events and so on will be collected and evaluated by applicability of the data, generated an analysis data set. Use the causal inference method of statistical analysis to observe the effectiveness and safety of intravitreal injection of Conbercept, and explore the effectiveness and safety of different doses in the treatment of retinopathy of prematurity.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conbercept | – | –In clinical treatment and research, the applied doses of Conbercept in patients with retinopathy of prematurity have been reduced compared with adults, mostly half of the adult dose. The commonly used exposure dose of intravitreal injection of Conbercept ophthalmic injection is 0.25mg/0.025ml.In addition, possible exposure doses are but not limited to 0.15mg/0.15ml, 0.1mg/ 0.1ml, 0.2mg/0.2ml, etc. |
| Ranibizumab | – | –In clinical treatment and research, the applied doses of Ranibizumab in patients with retinopathy of prematurity have been reduced compared with adults, mostly half of the adult dose. The commonly used exposure dose of intravitreal injection of Ranibizumab ophthalmic injection is 0.25mg/0.025ml.In addition, possible exposure doses are but not limited to 0.15mg/0.15ml, 0.1mg/ 0.1ml, 0.2mg/0.2ml, etc. |
| Laser Treatment | – | –In clinical and research studies, lasers are used to treat patients with retinopathy of prematurity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with retinopathy of prematurity in treatment of zone 1 (stage 1+, stage 2+, stage 3, stage 3+) or zone 2 (stage 2+, stage 3+) or AP-ROP (rapidly progressive posterior retinopathy of prematurity)
Key inclusion criteria (3 listed)
- Patient who are diagnosed as retinopathy of prematurity using clinical fundus screening;
- Patients at the initial stage of treatment whose one eye at least has the following condition: Stage 1+, Stage 2+, Stage 3, Stage 3+ in Zone 1; or Stage 2+, Stage 3+ in Zone 2; or those with AP-ROP according to the international ROP classification,;
- Patient for whom the first treatment is laser therapy, intravitreal injection of Conbercept or ranibizumab;
Key exclusion criteria (5 listed)
- Patients with neurological diseases that seriously affect visual function;
- Patient or his mother (during pregnancy) has received intravitreal or systemic anti-VEGF drug therapy for other diseases;
- Patients with insufficient data on treatment or medication;
- Patients who are followed up for less than 3 months after treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main effectiveness indicators
Time frame: 24 weeks
Proportion of eyes with no active retinopathy of prematurity and no structural adverse outcome (within 24 weeks after the first treatment; active retinopathy of prematurity is defined as additional lesions, vascular tortuosity, crest and other lesions having no alleviation but trend of progress after clinical treatment and new blood vessels continuing to exist or new born; poor structural outcomes are defined as adverse results such as retinal detachment, retinal traction or macular abnormalities after clinical treatment)
Main safety indicators
Time frame: 24weeks
The proportion of affected eyes with ocular AEs (within 24 weeks after the first treatment)
Primary endpoint
Time frame: 24 weeks
To evaluate the proportion of eyes with inactive retinopathy of prematurity and without structural adverse outcomes at 24 weeks after the first treatment (inactive retinopathy of prematurity is defined as the reduction in additional lesions, vascular tortuosity, ridges and other lesions after clinical treatment, showing no trend of progression, no persistent or newly developed neovascularization; no structural adverse outcome is defined as the absence of adverse outcomes such as retinal detachment, retinal traction, or macular abnormalities after clinical treatment)
12 secondary outcomes
Secondary endpoints
Time frame: at 1 week and 24 weeks
Secondary endpoints
Time frame: at 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: at 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Secondary endpoints
Time frame: within 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jianhong Liang principal investigator
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Chengdu Kanghong Biotech Co., Ltd. at 2 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main effectiveness indicators (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 19 Sep 2022.