NCT01478737

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Typical duration for phase_2

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

November 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4.4 years

First QC Date

November 21, 2011

Last Update Submit

January 28, 2024

Conditions

Proliferative Diabetic Retinopathy

Keywords

PDRPvitreous hemorrhagevitrectomy

Outcome Measures

Primary Outcomes (1)

  • Reoperation

    The proportion of patients that, due to re-bleeding within 12 months, have a second PPV

    12 months

Secondary Outcomes (1)

  • Rebleeding

    12 months

Study Arms (2)

Sham

SHAM COMPARATOR

Vitrectomy only

Procedure: Vitrectomy

Intravitreal Ozurdex

ACTIVE COMPARATOR

Intravitreal Ozurdex after vitrectomy

Drug: Intravitreal dexamethasone implant

Interventions

Intravitreal dexamethasone implantDRUG

Intravitreal Ozurdex after vitrectomy

Also known as: OZURDEX® (dexamethasone intravitreal implant)
Intravitreal Ozurdex
VitrectomyPROCEDURE

Vitrectomy only

Sham

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with vitreous hemorrhage undergoing PPV for PDRP

You may not qualify if:

  • Previous PPV
  • Vitreous hemorrhage of non-PDRP origin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Erik Eye Hospital

Stockholm, NonUS, 11282, Sweden

Location

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

Calcium DobesilateDexamethasoneVitrectomy

Condition Hierarchy (Ancestors)

Eye HemorrhageEye DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Anders Kvanta, PhD

    St. Erik Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

SE(1)