NCT00642226

Brief Summary

The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

7 years

First QC Date

March 19, 2008

Last Update Submit

January 3, 2014

Conditions

Branch Retinal Vein OcclusionMacular Edema

Keywords

Branch Retinal Vein OcclusionBRVOMacular EdemaTriamcinoloneVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity (ETDRS)

    12 and 36 Months

Secondary Outcomes (1)

  • Retinal thickening measured on OCT.

    12 and 36 Months

Study Arms (2)

1

ACTIVE COMPARATOR

Grid Laser

Procedure: Grid Laser

2

EXPERIMENTAL

Vitrectomy in combination with 20 mg triamcinolone

Procedure: Vitrectomy and 20 mg triamcinolone

Interventions

Grid LaserPROCEDURE

ETDRS Grid Laser

Also known as: Laser photocoagulation of macular edema
1
Vitrectomy and 20 mg triamcinolonePROCEDURE

Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate

Also known as: PPV with induction of posterior vitreous detachment
2

Eligibility Criteria

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

You may qualify if:

  • Macular edema secondary to BRVO
  • Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
  • Duration no shorter than 3 months
  • Duration no longer than 12 months

You may not qualify if:

  • Proliferations in study eye
  • Blod in vitreous cavity
  • Previous fundus laser treatment
  • BRVO with over 180˚ of ischemia on FA
  • Age under 18
  • Other eye condition which contribute to relevant loss of visual acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4018, Norway

Location

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Interventions

VitrectomyTriamcinolonePredictive Value of Tests

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedSensitivity and SpecificityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Johan Seland, PhD

    Helse Stavanger HF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 24, 2008

Study Start

November 1, 2006

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

NO(1)