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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-08

Study Completion Date

2019-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laser Photocoagulation

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

Group Type OTHER

Laser Photocoagulation

Intervention Type PROCEDURE

Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.

Dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

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

Intervention Type DRUG

Laser Photocoagulation

Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OZURDEX®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joanne Li

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.