Please note that due to a high volume of submissions, the ANZCTR is currently experiencing a delay in processing of submissions.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00168324




Registration number
NCT00168324
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
23/04/2019

Titles & IDs
Public title
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Scientific title
Secondary ID [1] 0 0
206207-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema 0 0
Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 700 µg Dexamethasone
Treatment: Drugs - 350 µg Dexamethasone
Other interventions - Sham Injection

Experimental: 700 µg Dexamethasone - 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.

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.

Sham Comparator: Sham Injection followed by 700 µg Dexamethasone - Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.


Treatment: Drugs: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.

Treatment: Drugs: 350 µg Dexamethasone
350 µg Dexamethasone intravitreal implant administered on Day 0.

Other interventions: Sham Injection
Sham injection on Day 0.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 180 Days
Secondary outcome [1] 0 0
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 at each visit are presented.
Timepoint [1] 0 0
Day 90, Day 180
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline, Day 90, Day 180
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, Day 90
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline, Day 180

Eligibility
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Czechia
State/province [4] 0 0
Brno
Country [5] 0 0
France
State/province [5] 0 0
Creteil
Country [6] 0 0
Germany
State/province [6] 0 0
Karlsruhe
Country [7] 0 0
Israel
State/province [7] 0 0
Rehovot
Country [8] 0 0
Mexico
State/province [8] 0 0
Tabacalera
Country [9] 0 0
Philippines
State/province [9] 0 0
Makati
Country [10] 0 0
Portugal
State/province [10] 0 0
Coimbra
Country [11] 0 0
South Africa
State/province [11] 0 0
Arcadia
Country [12] 0 0
Taiwan
State/province [12] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00168324
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications