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To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR).
Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.
The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not.
At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed.
The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conbercept | Experimental | intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery |
|
| control group | No Intervention | Pars plana vitrectomy alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept | Drug | Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| best corrected visual acuity | BCVA using a Landolt C acuity chart method | baseline to 24 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | postoperative complications | baseline to 24 weeks post-surgery |
| central retinal thickness | Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, one-dimensional images |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rong X Li, MD,PhD | Tianjin Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39207600 | Derived | Wazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29. |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
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| baseline to 24 weeks post-surgery |