NCT01566526

Brief Summary

The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 27, 2013

Completed
Last Updated

May 27, 2013

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

March 27, 2012

Results QC Date

March 27, 2013

Last Update Submit

March 27, 2013

Conditions

Retinal Vein OcclusionMacular Oedema

Outcome Measures

Primary Outcomes (1)

  • Time to OZURDEX® Re-Injection in the Study Eye

    The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.

    Up to 12 Months

Secondary Outcomes (6)

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye

    Baseline, 7 to 12 weeks following the last injection

  • Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye

    Baseline, Up to 12 Months

  • Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye

    Baseline, Up to 12 Months

  • Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection

    Baseline, 7 to 12 weeks following the last injection

  • Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Baseline, Up to 12 Months

  • +1 more secondary outcomes

Study Arms (1)

Patients Previously Treated with OZURDEX®

OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.

Drug: dexamethasone intravitreal implant 0.7 mg

Interventions

dexamethasone intravitreal implant 0.7 mgDRUG

OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.

Also known as: OZURDEX®
Patients Previously Treated with OZURDEX®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program.

You may qualify if:

  • Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
  • Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Interventions

DexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Vice President Medical Affairs,
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
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 27, 2013

Results First Posted

May 27, 2013

Record last verified: 2013-03

Locations

BE(1)