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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). 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. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.
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 - BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.
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 - BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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.
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 - Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased = 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased = 10%).
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
Gender
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
N/A
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
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)
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
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in
the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be
followed for 26 weeks.
Trial website
https://clinicaltrials.gov/show/NCT00799227
Trial related presentations / publications
Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.
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

Summary results
Other publications