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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.
Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental | Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy |
|
| Sham injection | Sham Comparator | Sham injection 3~7 days before vitrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative vitreous haemorrhage | To compare the incidence of the early postoperative vitreous haemorrhage between two arms | From day 1 to week 4 after the vitrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Best-corrected visual acuity (BCVA) at Month 3 | To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms. | Month 3 after vitrectomy |
| Mean Best-corrected visual acuity (BCVA) at Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peiquan Zhao | Contact | 13311620396 | Zhaopeiquan@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Peiquan Zhao | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo Eye Hospital | Ningbo | Zhejiang | 315012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19584650 | Result | Lo WR, Kim SJ, Aaberg TM Sr, Bergstrom C, Srivastava SK, Yan J, Martin DF, Hubbard GB 3rd. Visual outcomes and incidence of recurrent vitreous hemorrhage after vitrectomy in diabetic eyes pretreated with bevacizumab (avastin). Retina. 2009 Jul-Aug;29(7):926-31. doi: 10.1097/IAE.0b013e3181a8eb88. | |
| 21278146 | Result |
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| Sham injection | Other | Patients will receive single sham injection 3~7 days 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 |
|
|
To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.
| Month 6 after vitrectomy |
| Eye & Ent Hospital of Fudan University | Shanghai | 2000831 | China |
|
| Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine | Shanghai | 2000892 | China |
|
| Zhao LQ, Zhu H, Zhao PQ, Hu YQ. A systematic review and meta-analysis of clinical outcomes of vitrectomy with or without intravitreal bevacizumab pretreatment for severe diabetic retinopathy. Br J Ophthalmol. 2011 Sep;95(9):1216-22. doi: 10.1136/bjo.2010.189514. Epub 2011 Jan 27. |
| 28498374 | Result | Comyn O, Wickham L, Charteris DG, Sullivan PM, Ezra E, Gregor Z, Aylward GW, da Cruz L, Fabinyi D, Peto T, Restori M, Xing W, Bunce C, Hykin PG, Bainbridge JW. Ranibizumab pretreatment in diabetic vitrectomy: a pilot randomised controlled trial (the RaDiVit study). Eye (Lond). 2017 Sep;31(9):1253-1258. doi: 10.1038/eye.2017.75. Epub 2017 May 12. |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C005703 | salicylhydroxamic acid |
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| 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 |
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