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Trial registered on ANZCTR


Registration number
ACTRN12607000225415
Ethics application status
Approved
Date submitted
12/04/2007
Date registered
30/04/2007
Date last updated
30/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of intravitreal triamcinolone acetonide before pan retinal photocoagulation for improvement of visual acuity and macular edema in diabetic retinopathy
Scientific title
Efficacy of intravitreal triamcinolone acetonide before pan retinal photocoagulation for improvement of visual acuity and macular edema in diabetic retinopathy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic macular edema in severe non proliferative diabetic retinopathy (NPDR)or proliferative diabetic retinopathy(PDR) 1756 0
Condition category
Condition code
Metabolic and Endocrine 1847 1847 0 0
Diabetes
Eye 1848 1848 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with Severe NPDR or PDR who need panretinal photocoagulation(PRP) and have macular edema with same stage in both eyes are randomized to two groups. One eye is in the injection group The other eye is active control. in the first group 4 mg triamcinolone acetonide is injected intravitreally 1 week before first session of PRP . PRP is done in 3 sessions 1 week apart.
Intervention code [1] 1699 0
Treatment: Drugs
Comparator / control treatment
In the active control group just PRP is done. PRP is done in 3 sessions 1 week apart.
Control group
Active

Outcomes
Primary outcome [1] 2588 0
10 letter improvement of visual acuity on Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Timepoint [1] 2588 0
At baseline and at 1 month and 6 month
Secondary outcome [1] 4447 0
Changes of central macular thickness (CMT) in OCT (optical coherence tomography).
Timepoint [1] 4447 0
At baseline and at 1 month and 6 month.

Eligibility
Key inclusion criteria
All diabetic patients with severe NPDR or PDR and same stage macular edema in both eyes (Have or not have CSME in both eyes).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Tractional retinal detachment, glaucoma, corticosteroid responders, active ocular surface disease, media opacity precluding visibility of fundus details.

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
assessor and data analyst are blind
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 512 0
Iran, Islamic Republic Of
State/province [1] 512 0

Funding & Sponsors
Funding source category [1] 1995 0
University
Name [1] 1995 0
Tehran University of medical sciences
Country [1] 1995 0
Iran, Islamic Republic Of
Primary sponsor type
Hospital
Name
Eye Research Center, Farabi Eye Hospital
Address
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 1806 0
None
Name [1] 1806 0
nil
Address [1] 1806 0
Country [1] 1806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3702 0
Institutional Review of Board (IRB)and Ethics committee of Tehran University of Medical Sciences
Ethics committee address [1] 3702 0
Ethics committee country [1] 3702 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 3702 0
Approval date [1] 3702 0
01/10/2005
Ethics approval number [1] 3702 0
356

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27802 0
Address 27802 0
Country 27802 0
Phone 27802 0
Fax 27802 0
Email 27802 0
Contact person for public queries
Name 10888 0
Hamideh Shenazandi
Address 10888 0
Farabi Eye Hospital
Qazvin Square
Tehran
Country 10888 0
Iran, Islamic Republic Of
Phone 10888 0
+98 21 55410006-9
Fax 10888 0
+98 21 55421002
Email 10888 0
shenazandi@razi.tums.ac.ir
Contact person for scientific queries
Name 1816 0
Hamideh Shenazandi
Address 1816 0
Farabi Eye Hospital
Qazvin Square
Tehran
Country 1816 0
Iran, Islamic Republic Of
Phone 1816 0
+98 21 55410006-9
Fax 1816 0
+98 21 55421002
Email 1816 0
shenazandi@razi.tums.ac.ir

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
No additional documents have been identified.