A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
Dexamethasone Posterior Segment Drug Delivery System Versus Laser Photocoagulation in Patients With Diabetic Macular Edema
1 other identifier
interventional
284
2 countries
18
Brief Summary
This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2016
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedStudy Start
First participant enrolled
January 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedResults Posted
Study results publicly available
November 17, 2020
CompletedNovember 17, 2020
October 1, 2020
3.8 years
April 22, 2014
October 27, 2020
October 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Month 12
Secondary Outcomes (3)
Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
Baseline to Month 12
Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
Baseline to Month 12
Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
Baseline to Month 12
Study Arms (2)
Laser Photocoagulation
OTHERLaser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Dexamethasone
EXPERIMENTALDexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
Interventions
Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.
Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Eligibility Criteria
You may qualify if:
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Presence of macular edema
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
- Tigermed Consulting Co., Ltdcollaborator
Study Sites (18)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Beijing TongRen Hospital
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Zhongshan Ophthalmic Center, Sun Yet-Sen University
Guangzhou, Guangdong, 510060, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
The 2nd hospital of JiLin University
Changchun, Jilin, 130041, China
The Eye and ENT Hospital, Affiliated of Fudan University
Shanghai, Shanghai Municipality, 200031, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020, China
TianJin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384, China
Wenzhou Ophthalmic Centre
Wenzhou, Zhejiang, 325027, China
Asian Eye Institute
Makati City, National Capital Region, 1200, Philippines
Peregrine Eye and Laser Institute
Makati City, National Capital Region, 1209, Philippines
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Joanne Li
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 23, 2014
Study Start
January 8, 2016
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
November 17, 2020
Results First Posted
November 17, 2020
Record last verified: 2020-10