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Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept | Drug | Administered as an intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Percentage of participants having reactivation at or before week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before the first treatment (Day 0), Day 1, Week 1 and Week 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang | Contact | 02984771794 | wangys003@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
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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. |
| 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:
| 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. | 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. | Week 24 |
| Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| Department of Ophthalmology, Xianyang Rainbow Hospital | Recruiting | Xianyang | Shaanxi | 712000 | China |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |