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Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema

NCT02471651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-19

Study results available
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Summary

Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly used treatment options for individuals with diabetic macular edema. However, some patients continue to experience persistent diabetic macular edema and poor vision despite continued laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth factor injections. The purpose of this research study is to compare the effectiveness of using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for research participants with persistent diabetic macular edema (DME).

Conditions

Interventions

DRUG

Dexamethasone intravitreal implant (0.7 mg)

Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).

DRUG

Intravitreal anti-VEGF injection

This injection may be ranibizumab, bevacizumab, or aflibercept.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • California Retina Consultants

    lead OTHER

Principal Investigators

  • Gabriel Gordon, Ph.D. · California Retina Consultants

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-10-24
Completion
2018-10-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02471651 on ClinicalTrials.gov