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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121262
• Other study ID #: 206207-026
• Status: Completed
• Phase: Phase 3
• Start date: January 8, 2016
• Est. completion date: November 1, 2019

Study information

• Verified date: October 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone
Dexamethasone 700 µg intravitreal injection in the study eye on Day 1, Months 5, and 10.

Procedure:
• Laser Photocoagulation
Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital of Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing TongRen Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	People's Hospital of Peking University	Beijing	Beijing
China	The 2nd hospital of JiLin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Zhongshan Ophthalmic Center, Sun Yet-Sen University	Guangzhou	Guangdong
China	The First Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The Eye and ENT Hospital, Affiliated of Fudan University	Shanghai	Shanghai
China	Tianjin Eye Hospital	Tianjin	Tianjin
China	TianJin Medical University Eye Hospital	Tianjin	Tianjin
China	Wenzhou Ophthalmic Centre	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
Philippines	Asian Eye Institute	Makati City	Metro Manila
Philippines	Peregrine Eye and Laser Institute	Makati City	Metro Manila

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	Tigermed Consulting Co., Ltd

Countries where clinical trial is conducted

China,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to Month 12
Secondary	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.	Baseline to Month 12
Secondary	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.	Baseline to Month 12