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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
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Secondary ID [1]
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206207-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of =15 Letters From Baseline in the Study Eye
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Assessment method [1]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
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Timepoint [1]
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Baseline, Month 39/Final Visit
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Secondary outcome [1]
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Average Change From Baseline in BCVA in the Study Eye
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Assessment method [1]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
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Timepoint [1]
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Baseline, 39 Months
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Secondary outcome [2]
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Change From Baseline in BCVA in the Study Eye
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Assessment method [2]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
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Timepoint [2]
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Baseline, Month 39/Final Visit
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Secondary outcome [3]
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Percentage of Patients With a BCVA Improvement of =10 Letters From Baseline in the Study Eye
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Assessment method [3]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
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Timepoint [3]
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Baseline, Month 39/Final Visit
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Secondary outcome [4]
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Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
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Assessment method [4]
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OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. The average OCT retinal thickness is calculated across study visits for each patient. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
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Timepoint [4]
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Baseline, 39 Months
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Secondary outcome [5]
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10th Percentile for Time to BCVA Improvement of =15 Letters From Baseline in the Study Eye
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Assessment method [5]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of =15 letters from baseline in the study eye.
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Timepoint [5]
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Baseline, 39 Months
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Secondary outcome [6]
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Percentage of Patients With BCVA Improvement of =15 Letters From Baseline in the Study Eye at 3-month Intervals
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Assessment method [6]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
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Timepoint [6]
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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
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2012
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Sample size
Target
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Accrual to date
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Final
494
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Westmead
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Czech Republic
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State/province [3]
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Prague
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Country [4]
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Germany
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State/province [4]
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Hamburg
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Country [5]
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Israel
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State/province [5]
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Tel Aviv
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Country [6]
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Philippines
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State/province [6]
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Rockwell Center, Makati
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Country [7]
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Portugal
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State/province [7]
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Coimbra
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Country [8]
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South Africa
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State/province [8]
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Cape Town
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Country [9]
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Spain
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State/province [9]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone
for the treatment of diabetic macular edema.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00168389
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00168389
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