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Choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV) is a common vision-threatening complication and often affects adults of working age. Intravitreal injection of any anti-vascular endothelial growth factor (VEGF) drugs would significantly suppress the activity of the CNV and finally improve the visual acuity. However, more than half of the patients would need one or more further injection for the recurrence or uncontrolled with 1+pro re nata (PRN) treatment within one year, and whether increasing the initial loading of intravitreal injection of anti-VEGF would be more efficacy for the controlling the PM-CNV remained unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | patients were given intravitreal injection of Conbercept 0.5mg every month repeated for 3 months. Thereafter, intravitreal Conbercept 0.5mg injections should be administered in case CNV persisted or recurred (based on the assessment of defined criteria for retreatment) at a maximum frequency of once every 4 weeks through 12 months |
|
| Group B | Experimental | patients were given intravitreal injection of Conbercept 0.5mg every month repeated for 6 months.Thereafter, intravitreal Conbercept 0.5mg injections should be administered in case CNV persisted or recurred (based on the assessment of defined criteria for retreatment) at a maximum frequency of once every 4 weeks through 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3+PRN | Drug | intravitreal injection of Conbercept 0.5mg every month repeated for 3 months, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA change | the mean change in BCVA from the baseline to month 12 in patients with PM-CNV receiving Conbercept 0.5mg 3+PRN or 6+PRN | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate of PM-CNV | the number of recurrence of choroidal neovascularization secondary to pathologic myopia | 12 months |
| BCVA at 3 years | the change of best corrected visual acuity (BCVA) at 3 years |
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Inclusion Criteria:
Patients who are aged ≥18 years, male or female
Active choroidal neovascularization secondary to pathologic myopia
Presence of at least 1 of the following lesion types:
24≤BCVA≤78, at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) like VA chart ( 20/32-20/320 Snellen equivalent)
Visual loss only due to the presence of any eligible types of CNV related to pathologic myopia, based on clinical ocular findings, fluorescein angiography (FA), and optical coherence tomography (OCT) data.
Patients who are willing to participant in this study and sign the informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| lin lu | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| 6+PRN |
| Drug |
intravitreal injection of Conbercept 0.5mg every month repeated for 6 months |
|
| 36 months |
| The change of CNV size | the size of choroidal neovascularization as measured by OCT | 12 months |
| The treatment exposure | the number of total injection within 1 year and 3 years | 12 months |
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |