A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema

October 27, 2020 updated by: Allergan

Dexamethasone Posterior Segment Drug Delivery System Versus Laser Photocoagulation in Patients With Diabetic Macular Edema

This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Tongren Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Hospital
      • Beijing, Beijing, China, 100044
        • People's Hospital of Peking University
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital of Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yet-Sen University
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
    • Hunan
      • Changsha, Hunan, China, 410011
        • The second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Hospital of Nanjing Medical University
    • Jilin
      • Changchun, Jilin, China, 130041
        • The 2nd hospital of JiLin University
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • The Eye and ENT Hospital, Affiliated of Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300384
        • Tianjin Medical University Eye Hospital
      • Tianjin, Tianjin, China, 300020
        • TianJin eye hospital
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Wenzhou Ophthalmic Centre
  • Philippines
    • Metro Manila
      • Makati City, Metro Manila, Philippines, 1200
        • Asian Eye Institute
      • Makati City, Metro Manila, Philippines, 1209
        • Peregrine Eye and Laser Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Presence of macular edema

Exclusion Criteria:

  • Anticipated need for ocular surgery in the study eye during the study
  • Laser photocoagulation in the study eye within 3 months
  • Cataract surgery within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Laser Photocoagulation
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Procedure: Laser Photocoagulation
Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Experimental: Dexamethasone
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
Drug: Dexamethasone
Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.
Other Names:
  • OZURDEX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline to Month 12
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis.
Baseline to Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
Time Frame: Baseline to Month 12
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye.
Baseline to Month 12
Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
Time Frame: Baseline to Month 12
CRT was assessed using SD-OCT, a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis.
Baseline to Month 12
Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
Time Frame: Baseline to Month 12
FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Early and transit images were taken of the study eye. Mid- and late-phase images were taken of the study and non-study eye. Electronic FA images were collected for evaluation by a reading center. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis.
Baseline to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Collaborators

Tigermed Consulting Co., Ltd

Investigators

  • Study Director: Joanne Li, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2016

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206207-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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