NCT02181530

Brief Summary

This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

May 25, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

July 2, 2014

Results QC Date

April 10, 2015

Last Update Submit

May 21, 2015

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 a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. 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 improvement in the number of letters read means that the vision has improved.

    Baseline, 7 to 12 weeks following the first OZURDEX® injection

Secondary Outcomes (6)

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

    Baseline, Up to 17 Months

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

    Baseline, Up to 17 Months

  • Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)

    Baseline, 7 to 12 weeks following the first OZURDEX® injection

  • Time to Improvement of 2 Lines or More in BCVA in the Study Eye

    Baseline, Up to 17 Months

  • Time to Improvement of 3 Lines or More in BCVA in the Study Eye

    Baseline, Up to 17 Months

  • +1 more secondary outcomes

Study Arms (1)

OZURDEX®

Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.

Other: No Intervention

Interventions

No InterventionOTHER

No treatment (intervention) is being administered as part of this study.

OZURDEX®

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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 routine clinical practice.

You may qualify if:

  • Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
  • Received at least one injection of OZURDEX® in the study eye

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Warsaw, Poland

Location

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

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

July 2, 2014

First Posted

July 4, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 25, 2015

Results First Posted

May 25, 2015

Record last verified: 2015-05

Locations

PL(1)