NCT03690947

Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME

Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.

Detailed description

To investigate the efficacy of intravitreal ranibizumab injections compared to combination with Micropulse Laser in Chinese patients with visual impairment in DME. The result of the study will be used to support new therapy in DME patients in China.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Intravitreal Ranibizumab	All subjections received 3 initial Ranibizumab injections
PROCEDURE	Micropulse Laser	After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
DRUG	Intravitreal Ranibizumab as needed	After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-08-31
• Completion: 2021-09-30
• First posted: 2018-10-01
• Last updated: 2022-12-28

Locations

1 site across 1 country: China