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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00168389




Registration number
NCT00168389
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
206207-010
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
Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Timepoint [4] 0 0
Baseline, 39 Months
Secondary outcome [5] 0 0
10th Percentile for Time to BCVA Improvement of =15 Letters From Baseline in the Study Eye
Timepoint [5] 0 0
Baseline, 39 Months
Secondary outcome [6] 0 0
Percentage of Patients With BCVA Improvement of =15 Letters From Baseline in the Study Eye at 3-month Intervals
Timepoint [6] 0 0
Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, 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 first 12 months of study;
* 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
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
494
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Prague
Country [4] 0 0
Germany
State/province [4] 0 0
Hamburg
Country [5] 0 0
Israel
State/province [5] 0 0
Tel Aviv
Country [6] 0 0
Philippines
State/province [6] 0 0
Rockwell Center, Makati
Country [7] 0 0
Portugal
State/province [7] 0 0
Coimbra
Country [8] 0 0
South Africa
State/province [8] 0 0
Cape Town
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona

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/NCT00168389