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

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ClinicalTrials.gov Identifier: NCT03973138
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ranibizumab Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Outcomes and the Predictive Factors in Chinese Patients With Diabetic Macular Edema Treated With Ranibizumab
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: one year ]
    changes of best-corrected visual acuity


Secondary Outcome Measures :
  1. Central foveal thickness [ Time Frame: one year ]
    changes of central foveal thickness


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973138


Contacts
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Contact: Kunbei Lai 8602087331366 laikb@163.com
Contact: Chenjin Jin, ph.D. 13302209900 jinchj@126.com

Locations
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China, Guangdong
Kunbei Lai Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Kunbei Lai    18825135810    laikb@163.com   
Contact: Chenjin Jin    13302209900      
Principal Investigator: Chenjin Jin, ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Chenjin Jin, ph.D. Zhongshan Ophthalmic Center, Sun Yat-sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jin Chen-jin, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03973138    
Other Study ID Numbers: ZOC-IVRDME02
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin Chen-jin, Sun Yat-sen University:
Macular edema
ranibizumab
Mpredictive factor
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents