NCT01903720

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

July 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 21, 2016

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

July 16, 2013

Results QC Date

June 10, 2016

Last Update Submit

April 9, 2019

Conditions

Macular EdemaRetinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6

    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.

    Baseline, Month 6

Secondary Outcomes (11)

  • Change From Baseline in Central Retinal Thickness (CRT) at Month 6

    Baseline, Month 6

  • Change From Baseline in BCVA at Month 12

    Baseline, Month 12

  • Change From Baseline in CRT at Month 12

    Baseline, Month 12

  • Change From Baseline in BCVA at Each Visit

    Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

  • Change From Baseline in CRT at Each Visit

    Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

  • +6 more secondary outcomes

Study Arms (1)

OZURDEX®

EXPERIMENTAL

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.

Drug: dexamethasone implant

Interventions

dexamethasone implantDRUG

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.

Also known as: OZURDEX®
OZURDEX®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

  • Yoon YH, Kim JW, Lee JY, Kim IT, Kang SW, Yu HG, Koh HJ, Kim SS, Chang DJ, Simonyi S. Dexamethasone Intravitreal Implant for Early Treatment and Retreatment of Macular Edema Related to Branch Retinal Vein Occlusion: The Multicenter COBALT Study. Ophthalmologica. 2018;240(2):81-89. doi: 10.1159/000487547. Epub 2018 Apr 11.

    PMID: 29642062BACKGROUND

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

DexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 19, 2013

Study Start

July 16, 2013

Primary Completion

September 24, 2014

Study Completion

March 30, 2015

Last Updated

April 17, 2019

Results First Posted

July 21, 2016

Record last verified: 2019-04

Locations

KR(1)