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Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge related complications.
Eyes responding to panretinal photocoagulation can remain stable for decades, but incomplete responses and relapses can occur in a certain percent of diabetic patients showing as proliferative diabetic retinopathy. At present vitrectomy is the main intervention for those eyes with vitreous hemorrhage, proliferative membrane, and tractional retinal detachment. And the surgical procedure might be complicated because of intraoperative bleeding. And post-operative complications might be also involved. Perioperative use of intraocular anti-VEGF might be associated with less hemorrhage related complications and better visula acuity. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection one week before surgery. The investigators tried to make sure whether pre-operative injection of ranibizuman can reduce reduce intra-operative bleeding, reduce the frequency of using endodiathermy, decrease surgical time, improve microcurculation of retina, and elevte best-corrected visual acuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab | Experimental | Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy. |
|
| control | Sham Comparator | Sham intravitreal injection one week before vitrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | intravitreal injection of 0.5 mg ranibizumab before vitrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| perioperative hemorrhage of the surgical eye | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| size of retinal non-perfusion area assessed by fluorescene angiography | 3 month | |
| macular retinal thickness assessed with optical coherance tomography | 3 month | |
| Measure | Description | Time Frame |
|---|---|---|
| complications | other perioperative complications | 3 months |
| surgical time | 1 day | |
| grade of surgical difficulty |
Inclusion Criteria:
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 |
|---|---|
| D000069579 | Ranibizumab |
| C005703 | salicylhydroxamic acid |
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| sham | Drug | sham intravitreal injection before vitrectomy |
|
|
| pars plana vitrectomy | Procedure | surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina. |
|
|
| retinal vessel oxygen saturation measured with a retinal oximeter |
| 3 months |
| best-corrected visual acuity | 3 months |
| 1 day |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |