In:
Medicine, Ovid Technologies (Wolters Kluwer Health), Vol. 99, No. 35 ( 2020-08-28), p. e21992-
Abstract:
Diabetic macular edema (DME) can cause severe vision impairments for patients with diabetes. Recently, Conbercept has shown efficacy on DME with 3-monthly loading dose injection and pro re nata (PRN, 3+PRN) thereafter in retrospectivetrials. Furthermore, there are some other approaches have been recommended such as 2mg bimonthly (2q8) after 5 initial doses, or Conbercept 0.5mg treat-and-extend, however, some patients still have recurrence of the disease after treatment. Therefore, in order to identify more efficacy and safety approach on Conbercept inpatients with DME, a randomized controlled trial will be performed with 6-monthly loading dose injection and PRN (6+PRN) compared with 3+PRN treatments. Methods: This study is a multicenter, randomized control trial of Conbecept treating DME in China. Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited. All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment. Results: This study will provide a new powerful evidence of the efficacy and safety of Conbecept treating DME. Discussion: This RTC study will determine whether multiple treatments of Conbercept provide better effectiveness in patients with DME. Trial registration number: ChiCTR2000032728
Type of Medium:
Online Resource
ISSN:
0025-7974
,
1536-5964
DOI:
10.1097/MD.0000000000021992
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2020
detail.hit.zdb_id:
2049818-4
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