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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Timepoint [1] 0 0
Day 90, Day 180
Secondary outcome [2] 0 0
Change From Baseline in Retinal Thickness in the Study Eye
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
Timepoint [3] 0 0
Baseline, Day 90
Secondary outcome [4] 0 0
Percentage of Patients With a Change From Baseline in BCVA by Category
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
Sex
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
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
599
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00168324