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

Phase 1

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Ranibizumab

• Registration Number: NCT03973138
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-02
• Last Update Submitted: 2019-06-02
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1. patients (aged>18 years) with DME who had a best-corrected visual acuity (BCVA) between 20/32 and 20/200, and CRT≥300μm; 2) clinically significant DME confirmed by both fundus fluorescein angiography (FFA) and optical coherence tomography (OCT) (Spectralis HRA+OCT; Heidelberg Engineering, Germany); 3) decreased vision caused by foveal thickening from DME, which could not be explained by any other cause.

Exclusion Criteria

• 1. previous anti-VEGF or laser treatment; 2) proliferative diabetic retinopathy who required immediate panretinal photocoagulation; 3) active proliferative diabetic retinopathy; 4) other causes for macular edema, for example, branch retinal vein occlusion; 5) other causes of visual loss in the study; 6) unstable systemic conditions, for example, uncontrolled blood pressure, stroke, renal or kidney failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Ranibizumab	DME patients who were diagnosed through fundus manifestations and FFA examination were treated by intravitreal injections of ranibizumab under the pro re nata (PRN) treatment regimen.

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity	one year	changes of best-corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
Central foveal thickness	one year	changes of central foveal thickness

Trial Locations

Locations (1)

Kunbei Lai; 🇨🇳 Guangzhou, Guangdong, China