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

Phase 3

Completed

• Conditions: Macular Edema
• Interventions: Procedure: Laser Photocoagulation; Drug: Dexamethasone

• Registration Number: NCT02121262
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Study Start: 2016-01-08
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-10
• Results First Submitted: 2020-10-27
• Results First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Results First Posted: 2020-11-17
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Photocoagulation	Laser Photocoagulation	Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Dexamethasone	Dexamethasone	Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (18)

Wenzhou Ophthalmic Centre; 🇨🇳 Wenzhou, Zhejiang, China

Peregrine Eye and Laser Institute; 🇵🇭 Makati City, Metro Manila, Philippines

Beijing 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

Beijing Friendship Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing TongRen Hospital; 🇨🇳 Beijing, Beijing, China

Zhongshan Ophthalmic Center, Sun Yet-Sen University; 🇨🇳 Guangzhou, Guangdong, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

The First Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

The 2nd hospital of JiLin University; 🇨🇳 Changchun, Jilin, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tianjin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China

TianJin Medical University Eye Hospital; 🇨🇳 Tianjin, Tianjin, China

Asian Eye Institute; 🇵🇭 Makati City, Metro Manila, Philippines

The Eye and ENT Hospital, Affiliated of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China