A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion

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

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-16

Study Completion Date

2015-03-30

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 OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion

NCT01618266

Macular Edema Retinal Vein Occlusion

COMPLETED

Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea

NCT01976650

Retinal Vein Occlusion

COMPLETED

Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.

NCT01449682

Retinal Vein Occlusion Macular Edema

COMPLETED PHASE3

A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

NCT01571557

Macular Edema Retinal Vein Occlusion

COMPLETED

A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)

NCT01445626

Macular Edema

COMPLETED

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 Retinal Vein Occlusion

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

OZURDEX®

OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.

Group Type EXPERIMENTAL

dexamethasone implant

Intervention Type DRUG

OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.

Interventions

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

dexamethasone implant

OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.

Intervention Type DRUG

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 macular edema
* Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye

Exclusion Criteria

* Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
* Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
* Any active ocular infection in either eye

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No