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

NCT02121262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2020-11-17

Study results available
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Summary

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

Conditions

  • Macular Edema

Interventions

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.

Sponsors & Collaborators

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Joanne Li · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-08
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • China
  • Philippines

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121262 on ClinicalTrials.gov