drugset / Trial / NCT04464694
Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
Phase 4
Unknown
142 enrolled
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Novartis · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Timeline
- Start
- 2020-09-01
- Primary completion
- 2021-12-01
- Completion
- 2022-06-01
Publications
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |