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

Last updated: June 2, 2019
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Edema

Diabetic Retinopathy

Diabetic Macular Edema

Treatment

N/A

Clinical Study ID

NCT03973138
ZOC-IVRDME02
  • Ages 18-90
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 byboth fundus fluorescein angiography (FFA) and optical coherence tomography (OCT) (Spectralis HRA+OCT; Heidelberg Engineering, Germany); 3) decreased vision caused byfoveal thickening from DME, which could not be explained by any other cause.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Study Start date:
January 01, 2015
Estimated Completion Date:
January 01, 2020

Study 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.

Connect with a study center

  • Kunbei Lai

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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