A Phase 4 interventional study of Intravitreal Ranibizumab and Micropulse Laser in Diabetic Macular Edema, sponsored by Beijing Hospital. Completed at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Beijing Hospital · Phase 4, Interventional, and Treatment
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.
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 72 is above the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Intravitreal Ranibizumab · Procedure: Micropulse Laser
Drug: Intravitreal Ranibizumab · Drug: Intravitreal Ranibizumab as needed
All subjections received 3 initial Ranibizumab injections
Also known as: Lucentis
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
Also known as: Macular Laser Photocoagulation
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
Also known as: Lucentis
Best Corrected Visual Acuity changes
Compare the changes of BCVA between two groups
Time frame: 12 months
Central Macular Thickness changes
Compare the changes of CMT between two groups
Time frame: 12 months
Plan to share: Yes — Email yuxiaobing@sina.com for individual participant data
Supporting information: Study protocol
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Beijing Hospital