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| Name | Class |
|---|---|
| Shanghai Municipal Science and Technology Commission | OTHER_GOV |
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The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.
This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal conbercept+Panretinal coagulation | Experimental |
| |
| Panretinal coagulation | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept | Drug | Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best-corrected visual acuity (BCVA) | To assess the effects of two therapies on visual acuity | from baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in central subfield thickness | optical coherence tomography (OCT) for the assessment of central macular thickness | from baseline to month 12 |
| Fundus fluorescein angiography | fluorescein angiography to measure area of fluorescein leakage (FLA) |
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Inclusion Criteria:
Type II diabetic patients, 18 years and older, were included if the participants had:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Shen, MD | Contact | +86-021-64370045 | carl_shen2005@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi Shen, MD | Ruijin Hospital | Study Director |
| Qiong Zhang, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 20025 | China |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
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| Panretinal coagulation | Procedure | The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion. |
|
| from baseline to month 12 |
| Foveal avascular zone | Optical coherence tomography angiography (OCTA) for measurement of FAZ | from baseline to month 12 |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |