NCT01571557

Brief Summary

This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
573

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration 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

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

April 30, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 20, 2015

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

April 3, 2012

Results QC Date

June 22, 2015

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) in the Study Eye

    BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.

    Baseline, Week 12

Secondary Outcomes (3)

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

    Baseline, 48 Weeks

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

    Baseline, 48 Weeks

  • Mean Change From Baseline in Central Retinal Thickness

    Baseline, Week 24

Study Arms (1)

OZURDEX®

OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.

Drug: dexamethasone 700 ug intravitreal implant

Interventions

dexamethasone 700 ug intravitreal implantDRUG

dexamethasone 700 ug intravitreal implant administered according to standard of care.

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 retinal vein occlusion

You may qualify if:

  • Diagnosis of macular edema following retinal vein occlusion
  • Prescribed OZURDEX®

You may not qualify if:

  • Previous treatment with OZURDEX®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, Germany

Location

Related Publications (1)

  • Augustin AJ, Holz FG, Haritoglou C, Mayer WJ, Bopp S, Scheuerle AF, Maier M, Sekundo W, Sandner D, Shirlaw A, Hattenbach LO. Retrospective, observational study in patients receiving a dexamethasone intravitreal implant 0.7 mg for macular oedema secondary to retinal vein occlusion. Ophthalmologica. 2015;233(1):18-26. doi: 10.1159/000368840. Epub 2014 Dec 5.

    PMID: 25503473BACKGROUND

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
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
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

April 30, 2012

Primary Completion

March 31, 2014

Study Completion

June 30, 2014

Last Updated

April 19, 2019

Results First Posted

July 20, 2015

Record last verified: 2019-04

Locations

DE(1)