Combined Vitrectomy and Triamcinolone in Macular Edema Se... | NCT00642226

Studies
Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

NCT00642226

Sponsor

Helse Stavanger HF

Status

Terminated

Last Update Posted

Jan 6, 2014Estimated

Enrollment

34Actual

Phase

Phase 3

Conditions

Branch Retinal Vein Occlusion
Macular Edema

Interventions

Grid Laser
Vitrectomy and 20 mg triamcinolone

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3.2006.1159	Other Identifier	REK Vest, Norway
14836	Other Identifier	NSD, Norway

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Mar 19, 2008

First Submission Date that Met QC Criteria

Mar 19, 2008

First Posted Date

Mar 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2014

Last Update Posted Date

Jan 6, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Grid Laser	Procedure: Grid Laser
2	Experimental	Vitrectomy in combination with 20 mg triamcinolone	Procedure: Vitrectomy and 20 mg triamcinolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Grid Laser	Procedure	ETDRS Grid Laser	1	Laser photocoagulation of macular edema

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity (ETDRS)		12 and 36 Months

Secondary Outcomes

Measure	Description	Time Frame
Retinal thickening measured on OCT.		12 and 36 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan Seland, PhD	Helse Stavanger HF	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stavanger University Hospital, Department of Ophthalmology		Stavanger		4018	Norway

Condition Browse Module

MeSH Terms

ID	Term
D012170	Retinal Vein Occlusion
D008269	Macular Edema

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy
D014221	Triamcinolone
D011237	Predictive Value of Tests

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D011245	Pregnadienes
D011278	Pregnanes

Browse Leaves

Not provided

Browse Branches

Not provided