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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00168337




Registration number
NCT00168337
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
4/08/2014

Titles & IDs
Public title
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Scientific title
Secondary ID [1] 0 0
206207-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema 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 - Dexamethasone
Other interventions - Sham

Experimental: Dexamethasone 700 µg - 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Experimental: Dexamethasone 350 µg - 350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Sham comparator: Sham - Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.


Treatment: Drugs: Dexamethasone
350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Other interventions: Sham
Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

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
Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of =15 Letters From Baseline in the Study Eye
Timepoint [1] 0 0
Baseline, Month 39/Final Visit
Secondary outcome [1] 0 0
Average Change From Baseline in BCVA in the Study Eye
Timepoint [1] 0 0
Baseline, 39 Months
Secondary outcome [2] 0 0
Change From Baseline in BCVA in the Study Eye
Timepoint [2] 0 0
Baseline, Month 39/Final Visit
Secondary outcome [3] 0 0
Percentage of Patients With a BCVA Improvement of =10 Letters From Baseline in the Study Eye
Timepoint [3] 0 0
Baseline, Month 39/Final Visit
Secondary outcome [4] 0 0
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Timepoint [4] 0 0
Baseline, Month 39/Final Visit

Eligibility
Key inclusion criteria
Key

* 18 years of age or older with diabetic macular edema;
* 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
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;
* 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 outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Colombia
State/province [4] 0 0
Bogota
Country [5] 0 0
France
State/province [5] 0 0
Dijon
Country [6] 0 0
Hungary
State/province [6] 0 0
Budapest
Country [7] 0 0
India
State/province [7] 0 0
New Delhi
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
Poland
State/province [11] 0 0
Warszawa
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taipei
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London

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.