NCT03973138

Visual Outcomes and the Predictive Factors in Chinese Patients With Diabetic Macular Edema Treated With Ranibizumab

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME).

Detailed description

The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME). Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), as well as predictive factors including best-corrected visual acuity (BCVA) were assessed.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Ranibizumab	DME patients who were diagnosed through fundus manifestations and FFA examination were treated by intravitreal injections of ranibizumab (0.5mg Lucentis®; Genentech, South San Francisco, CA) under the pro re nata (PRN) treatment regimen. The retreatment were conducted if BCVA was reduced by 0.1 logarithm of the minimal angle of resolution (logMAR) value or more from maximum acuity or if OCT central subfield thickness was more than 300μm.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-06-04
• Last updated: 2019-06-04

Locations

1 site across 1 country: China