Clinical trial NCT02121262: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2014-04-23
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
timeFrame: Baseline to Month 12
measure: Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
timeFrame: Baseline to Month 12
measure: Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital of Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing TongRen Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yet-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: The First Hospital of Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: The 2nd hospital of JiLin University
state: Jilin
city: Shanghai
country: China
facility: The Eye and ENT Hospital, Affiliated of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
city: Tianjin
country: China
facility: TianJin Medical University Eye Hospital
state: Tianjin
city: Wenzhou
country: China
facility: Wenzhou Ophthalmic Centre
state: Zhejiang
city: Makati City
country: Philippines
facility: Asian Eye Institute
state: Metro Manila
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Institute
state: Metro Manila
Study officials:
affiliation: Allergan
name: Joanne Li
role: STUDY_DIRECTOR
References: