NCT01539577

Brief Summary

This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
875

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

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

February 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

4 years

First QC Date

February 22, 2012

Last Update Submit

April 18, 2016

Conditions

Retinal Vein OcclusionMacular EdemaUveitis, Posterior

Outcome Measures

Primary Outcomes (2)

  • Incidence of Patients Reporting Serious Adverse Events

    2 years

  • Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest

    The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement.

    2 years

Study Arms (1)

OZURDEX®

OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice.

Drug: dexamethasone 700 μg intravitreal implant

Interventions

dexamethasone 700 μg intravitreal implantDRUG

dexamethasone 700 μg intravitreal implant administered according to general clinical practice.

Also known as: OZURDEX®
OZURDEX®

Eligibility Criteria

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

Patients with macular oedema due to CRVO or BRVO or non-infectious uveitis

You may qualify if:

  • Macular oedema following either BRVO or CRVO or non-infectious uveitis
  • Requires treatment with OZURDEX®

You may not qualify if:

  • Current participation in any clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Paris, France

Location

Unknown Facility

Ulm, Germany

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Bradford, West Yorks, United Kingdom

Location

MeSH Terms

Conditions

Retinal Vein OcclusionMacular EdemaUveitis, Posterior

Interventions

DexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal DegenerationPanuveitisUveitisUveal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 27, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

FR(1)GB(1)ES(1)DE(1)