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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00799227




Registration number
NCT00799227
Ethics application status
Date submitted
26/11/2008
Date registered
27/11/2008
Date last updated
23/04/2019

Titles & IDs
Public title
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Scientific title
Secondary ID [1] 0 0
206207-018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema 0 0
Vitrectomy 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

Experimental: 700 µg Dexamethasone Implant - 700 µg dexamethasone implant in the study eye at Day 1


Treatment: Drugs: Dexamethasone
700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Central Retinal Thickness in the Study Eye
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [2] 0 0
Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye
Timepoint [2] 0 0
Baseline, Week 26
Secondary outcome [3] 0 0
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
Timepoint [3] 0 0
Baseline, Week 26

Eligibility
Key inclusion criteria
* 18 years of age or older with diabetic macular edema
* History of vitrectomy
* Central retinal thickness = 275 µm
* Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
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 during the study period
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Uncontrolled systemic disease
* Known allergy to the study medication
* Known steroid-responder
* Use of systemic steroids
* Female subjects that are pregnant, nursing or planning a pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW
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
North Carolina

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/NCT00799227