Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000603314
Ethics application status
Approved
Date submitted
3/12/2008
Date registered
3/12/2008
Date last updated
3/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open-Label, Dose Escalation Study of the Safety and Tolerability of 20089 (Triamcinolone Acetonide Intravitreal Injection) in the Treatment of Patients with Cystoid Macular Edema Associated with Retinal Vein Occlusion or Cataract Surgery
Scientific title
An Open-Label, Dose Escalation Study of the Safety and Tolerability of 20089 (Triamcinolone Acetonide Intravitreal Injection) in the Treatment of Patients with Cystoid Macular Edema Associated with Retinal Vein Occlusion or Cataract Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystoid Macular Edema 4054 0
Condition category
Condition code
Eye 4263 4263 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravitreal injection of extended release triamcinolone acetonide for treatment of macular edema. Each patient will receive only one injection. The first cohort of five patients will all receive the 6.9 mg injection. The second cohort of five patients will receive the 13.8 mg injection.
Intervention code [1] 3778 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5147 0
Safety of drug in the eye at Day 60 timepoint as measured by intraocular pressure rise, slit lamp examination for anterior chamber cells and flare, presence of cataract, infection, hemorrhage or retinal detachment.
Timepoint [1] 5147 0
1 day, 7 days, 30 days, 60 days, 120 days, 180 days, 270 days, 360 days
Secondary outcome [1] 8666 0
reduction of macular edema as measured by optical coherence tomography
Timepoint [1] 8666 0
1 day, 7 days, 30 days, 60 days, 120 days, 180 days, 270 days, 360 days

Eligibility
Key inclusion criteria
Cystoid Macular Edema associated with retinal vein occlusion or post cataract surgery
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Visual acuity not likely to be improved by treatment; recent treatment by other intravitreal therapies or laser therapy

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



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1424 0
United States of America
State/province [1] 1424 0
CA

Funding & Sponsors
Funding source category [1] 4237 0
Commercial sector/Industry
Name [1] 4237 0
Icon Bioscience
Country [1] 4237 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Icon Bioscience
Address
1253 Reamwood Ave.
Sunnyvale, CA 94089
USA
Country
United States of America
Secondary sponsor category [1] 3810 0
None
Name [1] 3810 0
Address [1] 3810 0
Country [1] 3810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6289 0
Western Institutional Review Board
Ethics committee address [1] 6289 0
Western Institutional Review Board
3535 7th Ave. S.W.
PO Box 12029
Olympia, WA 98508
Ethics committee country [1] 6289 0
United States of America
Date submitted for ethics approval [1] 6289 0
09/06/2007
Approval date [1] 6289 0
Ethics approval number [1] 6289 0

Summary
Brief summary
The purpose of this study is to test the safety and tolerability of a extended duration drug delivery system for the eye.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29188 0
Address 29188 0
Country 29188 0
Phone 29188 0
Fax 29188 0
Email 29188 0
Contact person for public queries
Name 12345 0
W. Sandy White
Address 12345 0
1253 Reamwood Ave.
Sunnyvale, CA 94089
Country 12345 0
United States of America
Phone 12345 0
+1 408-734-8188
Fax 12345 0
Email 12345 0
[email protected]
Contact person for scientific queries
Name 3273 0
W. Sandy White
Address 3273 0
1253 Reamwood Ave.
Sunnyvale, CA 94089
Country 3273 0
United States of America
Phone 3273 0
+1 408-734-8188
Fax 3273 0
Email 3273 0
info@iconbioscience.

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISustained-Release Intravitreal Liquid Drug Delivery Using Triamcinolone Acetonide for Cystoid Macular Edema in Retinal Vein Occlusion2011https://doi.org/10.1016/j.ophtha.2010.12.029
N.B. These documents automatically identified may not have been verified by the study sponsor.