NCT00799227

Brief Summary

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

August 4, 2014

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

November 26, 2008

Results QC Date

July 10, 2014

Last Update Submit

April 10, 2019

Conditions

Diabetic Macular EdemaVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Central Retinal Thickness in the Study Eye

    Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.

    Baseline, Week 26

Secondary Outcomes (3)

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Baseline, Week 26

  • Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye

    Baseline, Week 26

  • Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye

    Baseline, Week 26

Study Arms (1)

700 µg Dexamethasone Implant

EXPERIMENTAL

700 µg dexamethasone implant in the study eye at Day 1

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.

Also known as: Posurdex®, OZURDEX®
700 µg Dexamethasone Implant

Eligibility Criteria

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

You may qualify if:

  • years of age or older with diabetic macular edema
  • History of vitrectomy
  • Central retinal thickness ≥ 275 µm
  • Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

You may not qualify if:

  • Known anticipated need for ocular surgery during the study period
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Uncontrolled systemic disease
  • Known allergy to the study medication
  • Known steroid-responder
  • Use of systemic steroids
  • Female subjects that are pregnant, nursing or planning a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Sydney, New South Wales, Australia

Location

Related Publications (1)

  • Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.

    PMID: 21487341BACKGROUND

MeSH Terms

Interventions

DexamethasoneCalcium Dobesilate

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Results Point of Contact

Title
Therapeutic Area Head,
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
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 23, 2019

Results First Posted

August 4, 2014

Record last verified: 2019-04

Locations

US(1)AU(1)