NCT04186702

New Concepts in Diabetic Macular Edema (DME)

New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.

Detailed description

Settings and Design: Randomized clinical study Subjects and Methods: investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.

Conditions

• Diabetes Mellitus, With Complications

Interventions

Type	Name	Description
PROCEDURE	INTRAVITREAL RANIBIZUMAB INJECTION	interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)

Timeline

• Start date: 2014-09-10
• Primary completion: 2016-10-01
• Completion: 2017-09-09
• First posted: 2019-12-05
• Last updated: 2019-12-05