NCT00168324

Brief Summary

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
599

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

Geographic Reach
12 countries

12 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

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 26, 2009

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Results QC Date

July 15, 2009

Last Update Submit

April 11, 2019

Conditions

Macular EdemaRetinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Cumulative Response Rate of 15 or More Letter Improvement

    The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.

    Up to 180 Days

Secondary Outcomes (4)

  • Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Day 90, Day 180

  • Change From Baseline in Retinal Thickness in the Study Eye

    Baseline, Day 90, Day 180

  • Percentage of Patients With a Change From Baseline in BCVA by Category

    Baseline, Day 90

  • Percentage of Patients With a Change From Baseline in BCVA by Category

    Baseline, Day 180

Study Arms (3)

700 µg Dexamethasone

EXPERIMENTAL

700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.

Drug: 700 µg Dexamethasone

350 µg Dexamethasone followed by 700 µg Dexamethasone

EXPERIMENTAL

350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.

Drug: 700 µg DexamethasoneDrug: 350 µg Dexamethasone

Sham Injection followed by 700 µg Dexamethasone

SHAM COMPARATOR

Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.

Drug: 700 µg DexamethasoneOther: Sham Injection

Interventions

700 µg DexamethasoneDRUG

700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.

Also known as: Posurdex®
350 µg Dexamethasone followed by 700 µg Dexamethasone700 µg DexamethasoneSham Injection followed by 700 µg Dexamethasone
350 µg DexamethasoneDRUG

350 µg Dexamethasone intravitreal implant administered on Day 0.

Also known as: Posurdex®
350 µg Dexamethasone followed by 700 µg Dexamethasone
Sham InjectionOTHER

Sham injection on Day 0.

Sham Injection followed by 700 µg Dexamethasone

Eligibility Criteria

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

You may qualify if:

  • years of age or older with macular edema resulting from retinal vein occlusion
  • Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
  • Visual acuity in other eye no worse than 20/200

You may not qualify if:

  • Known anticipated need for ocular surgery within next 12 months
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Diabetic retinopathy
  • Uncontrolled systemic disease
  • Known steroid-responder
  • Use of systemic steroids
  • Use of warfarin/heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Sydney, Australia

Location

Unknown Facility

Graz, Austria

Location

Unknown Facility

Halifax, Nova Scotia, Canada

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Créteil, France

Location

Unknown Facility

Karlsruhe, Germany

Location

Unknown Facility

Rehovot, Israel

Location

Unknown Facility

Tabacalera, Mexico

Location

Unknown Facility

Makati, Philippines

Location

Unknown Facility

Coimbra, Portugal

Location

Unknown Facility

Arcadia, South Africa

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Related Publications (1)

  • Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.

    PMID: 20417567BACKGROUND

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

Dexamethasonesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

October 1, 2004

Primary Completion

March 1, 2008

Study Completion

October 1, 2008

Last Updated

April 23, 2019

Results First Posted

August 26, 2009

Record last verified: 2019-04

Locations

PT(1)TW(1)IL(1)US(1)AU(1)CA(1)FR(1)CZ(1)ME(1)PH(1)ZA(1)DE(1)