Intravitreal Ozurdex After Pars Plana Vitrectomy for Prol... | NCT01478737

Studies
Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

NCT01478737

Sponsor

Anders Kvanta

Status

Completed

Last Update Posted

Jan 30, 2024Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Proliferative Diabetic Retinopathy

Interventions

Intravitreal dexamethasone implant
Vitrectomy

Countries

Sweden

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

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Nov 21, 2011

First Submission Date that Met QC Criteria

Nov 22, 2011

First Posted Date

Nov 23, 2011Estimated

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 28, 2024

Last Update Posted Date

Jan 30, 2024Actual

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

To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).

Detailed Description

To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sham	Sham Comparator	Vitrectomy only	Procedure: Vitrectomy
Intravitreal Ozurdex	Active Comparator	Intravitreal Ozurdex after vitrectomy	Drug: Intravitreal dexamethasone implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal dexamethasone implant	Drug	Intravitreal Ozurdex after vitrectomy	Intravitreal Ozurdex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reoperation	The proportion of patients that, due to re-bleeding within 12 months, have a second PPV	12 months

Secondary Outcomes

Measure	Description	Time Frame
Rebleeding	The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:

Previous PPV
Vitreous hemorrhage of non-PDRP origin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anders Kvanta, PhD	St. Erik Eye Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Erik Eye Hospital		Stockholm	NonUS	11282	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D014823	Vitreous Hemorrhage

Ancestor Terms

ID	Term
D005130	Eye Hemorrhage
D005128	Eye Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002123	Calcium Dobesilate
D003907	Dexamethasone
D014821	Vitrectomy

Ancestor Terms

ID	Term
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided