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

Primary Purpose

Macular Edema

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Laser Photocoagulation
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First Hospital
  • People's Hospital of Peking University
  • Beijing Friendship Hospital of Capital Medical University
  • Beijing Hospital
  • Beijing TongRen Hospital
  • Peking Union Medical College Hospital
  • Zhongshan Ophthalmic Center, Sun Yet-Sen University
  • Renmin Hospital of Wuhan University
  • The Second Xiangya Hospital of Central South University
  • The First Hospital of Nanjing Medical University
  • The 2nd hospital of JiLin University
  • The Eye and ENT Hospital, Affiliated of Fudan University
  • West China Hospital, Sichuan University
  • Tianjin Eye Hospital
  • TianJin Medical University Eye Hospital
  • Wenzhou Ophthalmic Centre
  • Asian Eye Institute
  • Peregrine Eye and Laser Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Laser Photocoagulation

Dexamethasone

Arm Description

Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.

Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.

Outcomes

Primary Outcome Measures

Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
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.

Secondary Outcome Measures

Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
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.
Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
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.
Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
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.

Full Information

First Posted
April 22, 2014
Last Updated
October 27, 2020
Sponsor
Allergan
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02121262
Brief Title
A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
Official Title
Dexamethasone Posterior Segment Drug Delivery System Versus Laser Photocoagulation in Patients With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2016 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Photocoagulation
Arm Type
Other
Arm Description
Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
OZURDEX®
Intervention Description
Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.
Intervention Type
Procedure
Intervention Name(s)
Laser Photocoagulation
Intervention Description
Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Primary Outcome Measure Information:
Title
Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
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.
Time Frame
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
Description
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.
Time Frame
Baseline to Month 12
Title
Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
Description
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.
Time Frame
Baseline to Month 12
Title
Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
Description
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.
Time Frame
Baseline to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Li
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
People's Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Friendship Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing TongRen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Zhongshan Ophthalmic Center, Sun Yet-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The First Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The 2nd hospital of JiLin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
The Eye and ENT Hospital, Affiliated of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
TianJin Medical University Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300384
Country
China
Facility Name
Wenzhou Ophthalmic Centre
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
Asian Eye Institute
City
Makati City
State/Province
Metro Manila
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Peregrine Eye and Laser Institute
City
Makati City
State/Province
Metro Manila
ZIP/Postal Code
1209
Country
Philippines

12. IPD Sharing Statement

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

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