CClinicalTrials.gg
Sign In
CompletedNCT00168298Updated Apr 23, 2019Results posted

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

A Phase 3 interventional study of 700 µg Dexamethasone and 350 µg Dexamethasone in Macular Edema and Retinal Vein Occlusion, sponsored by Allergan. Completed at 13 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by Allergan · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2004, registered Sep 2005).
Phase
Phase 3
Study type
Interventional
Enrollment
668
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Macular Edema
  • Retinal Vein Occlusion
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 668 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 18 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

Key Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
668 participants (actual)

Study arms

  • Experimental
    700 µg Dexamethasone

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

    Drug: 700 µg Dexamethasone

  • Experimental
    350 µg Dexamethasone followed by 700 µg Dexamethasone

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

    Drug: 700 µg Dexamethasone · Drug: 350 µg Dexamethasone

  • Sham comparator
    Sham Injection followed by 700 µg Dexamethasone

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

    Drug: 700 µg Dexamethasone · Other: Sham Injection

Interventions

  • Drug700 µg Dexamethasone

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

    Also known as: Posurdex®

  • Drug350 µg Dexamethasone

    350 µg Dexamethasone intravitreal implant administered on Day 0.

    Also known as: Posurdex®

  • OtherSham Injection

    Sham injection on Day 0.

06

What researchers measure

Primary outcomes

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

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

    Time frame: Day 180

Secondary outcomes

  1. Change From Baseline in Retinal Thickness in the Study Eye

    Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.

    Time frame: Baseline, Day 90, Day 180

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

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.

    Time frame: Baseline, Day 90

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

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.

    Time frame: Baseline, Day 180

07

Results

Posted Aug 26, 2009

Participant flow

Double-Blind Period
Participant flow — Double-Blind Period
Milestone700 µg Dexamethasone350 µg Dexamethasone Followed by 700 µg DexamethasoneSham Injection Followed by 700 µg Dexamethasone
Started226218224
Completed214206209
Not completed121215
Open-Label Period
Participant flow — Open-Label Period
Milestone700 µg Dexamethasone350 µg Dexamethasone Followed by 700 µg DexamethasoneSham Injection Followed by 700 µg Dexamethasone
Started179173168
Completed172168160
Not completed758

Outcome measures

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

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

Time frame:
Day 180
Reported as:
Number · Number of Participants
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Number of Participants700 µg Dexamethasone350 µg DexamethasoneSham Injection
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye534838
SecondaryChange From Baseline in Retinal Thickness in the Study Eye

Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.

Time frame:
Baseline, Day 90, Day 180
Reported as:
Mean · Microns (µm)
Change From Baseline in Retinal Thickness in the Study Eye
Microns (µm)700 µg Dexamethasone350 µg DexamethasoneSham Injection
Baseline573.6 ± 189.08566.6 ± 219.63542.5 ± 185.64
Change from Baseline at Day 90-215.6 ± 207.62-205.5 ± 216.25-91.1 ± 191.85
Change from Baseline at Day 180-132.1 ± 207.20-150.5 ± 220.78-127.4 ± 197.77
SecondaryPercentage of Patients With a Change From Baseline in BCVA by Category

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.

Time frame:
Baseline, Day 90
Reported as:
Number · Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category
Percentage of Patients700 µg Dexamethasone350 µg DexamethasoneSham Injection
≥15 Letters Improvement21.225.713.8
≥5 and <15 Letters Improvement45.139.037.1
No Change (Between -5 to +5 Letters)25.726.629.9
≥5 and <15 Letters Worsening4.46.411.2
≥15 Letters Worsening3.52.38.0
SecondaryPercentage of Patients With a Change From Baseline in BCVA by Category

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.

Time frame:
Baseline, Day 180
Reported as:
Number · Percentage of Patients
Percentage of Patients With a Change From Baseline in BCVA by Category
Percentage of Patients700 µg Dexamethasone350 µg DexamethasoneSham Injection
≥15 Letters Improvement23.521.617.0
≥5 and <15 Letters Improvement35.033.928.6
No Change (Between -5 to +5 Letters)27.028.928.6
≥5 and <15 Letters Worsening8.010.613.8
≥15 Letters Worsening6.65.012.1

Adverse events

Collected over Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
700 µg Dexamethasone—16/225 (7.1%)168/225 (74.7%)
350 µg Dexamethasone—7/215 (3.3%)145/215 (67.4%)
Sham Injection—17/221 (7.7%)94/221 (42.5%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
Event700 µg Dexamethasone350 µg DexamethasoneSham Injection
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2251/2150/221
Myocardial infarctionCardiac disorders1/2251/2150/221
Cerebrovascular accidentNervous system disorders0/2251/2151/221
Angina pectorisCardiac disorders0/2251/2150/221
Atrial septal defectCongenital, familial and genetic disorders0/2251/2150/221
Chronic lymphocytic leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2251/2150/221
Parkinson's diseaseNervous system disorders0/2251/2150/221
Cardiac failure congestiveCardiac disorders1/2250/2151/221
Renal failure acuteRenal and urinary disorders1/2250/2151/221
Angina unstableCardiac disorders0/2250/2151/221
Most frequent other events
Most frequent other events
Event700 µg Dexamethasone350 µg DexamethasoneSham Injection
Intraocular pressure increasedInvestigations60/22556/2155/221
Conjunctival haemorrhageEye disorders46/22537/21537/221
Conjunctival hyperaemiaEye disorders18/22516/21513/221
Eye painEye disorders18/22510/21510/221
MaculopathyEye disorders8/22515/2156/221
Retinal exudatesEye disorders6/2252/21512/221
HypertensionVascular disorders12/2259/21511/221

Baseline characteristics

Age, Customized
Age, Customized(participants)700 µg Dexamethasone350 µg Dexamethasone Followed by 700 µg DexamethasoneSham Injection Followed by 700 µg DexamethasoneTotal
<45 years14151342
45-65 years109108111328
>65 years10395100298
Sex: Female, Male
Sex: Female, Male(Participants)700 µg Dexamethasone350 µg Dexamethasone Followed by 700 µg DexamethasoneSham Injection Followed by 700 µg DexamethasoneTotal
Female115102101318
Male111116123350
08

Study locations

13 sites
  • Houston, Texas, United States
  • Sao Paulo, Brazil
  • Mississauga, Ontario, Canada
  • Bogota, Colombia
  • Kowloon, Hong Kong
  • Tamil Nadu, India
  • Udine, Italy
  • Seoul, Korea, Republic of
  • Auckland, New Zealand
  • Poznan, Poland
  • Singapore, Singapore
  • Alicante, Spain
  • London, United Kingdom
09

References and documents

Publications

  • 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. PubMed 20417567 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00168298
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Nov 1, 2004
Primary completion
Mar 1, 2008
Completion
Sep 5, 2008
Results posted
Aug 26, 2009
Last update
Apr 23, 2019

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Macular Edema→

Other studies from this sponsor

Allergan

Start the discussion