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Trial registered on ANZCTR


Registration number
ACTRN12613000249752
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
4/03/2013
Date last updated
4/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Use of Intravitreal Injection of Triamcinolone Acetonide in Diabetic Patients to Reduce Diabetic Macular Edema
Scientific title
The Use of Intravitreal Injection of Triamcinolone Acetonide in Diabetic Patients to Reduce Diabetic Macular Edema
Secondary ID [1] 282027 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic macular edema 288475 0
Condition category
Condition code
Eye 288821 288821 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nineteen patients with bilateral diabetic macular edema were included, one eye for every patient underwent intravitreal injection of 4mg triamcinolone acetonide (group A, 19 eyes) and the other eye of the same patient underwent intravitreal injection of 8mg triamcinolone acetonide (group B, 19 eyes), the selection of which eye to receive either dose was random. The patients were followed up for six months after injection , complete Ophthalmological examination and optical coherent topography were done.
Intervention code [1] 286615 0
Treatment: Drugs
Comparator / control treatment
Group A and Group B both were active Intervention
Control group
Active

Outcomes
Primary outcome [1] 288959 0
control of diabetic macular edema (DME), detection of DME was done with Optical Coherence Tomography.( medical Equipment)
Timepoint [1] 288959 0
six months follow up after injection.
Secondary outcome [1] 301441 0
follow up of intraocular pressure (IOP) rise after injection. measurement was done by Goldmann applanation Tonometer mounted on slit lamp..
Timepoint [1] 301441 0
follow up of intraocular pressure rise after injection for six months after injection

Eligibility
Key inclusion criteria
The major eligibility criteria for the study eyes included the following: (1) best-corrected visual acuity letter score between 20/40 and 20/320; (2) definite retinal thickening resulting from DME on clinical examination involving the center of the macula assessed to be the main cause of visual loss; (3) retinal thickness measured with optical coherence tomography (OCT) of 250 micro m or more in the central subfield ;(4) Grid laser treatment was done at least three months earlier.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Principal exclusion criteria included; (1) prior treatment with intravitreal corticosteroids (at any time), peribulbar steroid injection within the prior 6 months, or pars plana vitrectomy (at any time); (2) a history of glaucoma or steroid-induced IOP elevation that required IOP-lowering treatment; (3) average intraocular pressure of 23 mm Hg or more after three preinjection evaluations; (4) eyes with ischemic maculopathy and (5) patients with foveal traction detected with OCT.

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)
Patients with bilateral diffuse DME were included where one eye received intravitreal TA 4mg and the other eye of the same patient received intravitreal TA 8mg. The selection of which eye to receive either dose was random ( central randomisation was done by computer).Allocation involved contacting the holder of the allocation schedule who was at central administration site.
The time for intravitreal injection between both eyes of the same patient was one week
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients with bilateral advanced diabetic macular edema was selected.
randomization was done in selection of which eye will receive 4mg and the other eye will receive 8mg. Simple randomisation by using a randomisation table created by computer software
so sometimes the right eye receive either 4 or 8 mg and vice verse.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
patients) with diabetic macular edema, defined according to the Early Treatment Diabetic Retinopathy This prospective Interventional two-arm dose-response study included 38 eyes (19 Study (ETDRS) (2). The patients were 17 females and two males.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Collected data were coded, entered and analyzed using Microsoft Excel software. Data were then imported into Statistical Package for the Social Sciences (SPSS version 16.0) software for analysis. Baseline characteristics of the study population were presented as frequencies and percentages (%) in qualitative data or mean values and standard deviations (SD) in quantitative data. Differences between frequencies were compared by Chi-square. Differences between means were compared by Wilcoxon rank-sum test. P-value of < 0.05 was considered significant. Pearson correlation coefficient test was used to evaluate the correlations between the studied variables. Analysis Of Variance (ANOVA) test was performed for repeated measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2010
Actual
30/03/2010
Date of last participant enrolment
Anticipated
16/03/2011
Actual
29/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment outside Australia
Country [1] 4884 0
Egypt
State/province [1] 4884 0
Ismailia

Funding & Sponsors
Funding source category [1] 286801 0
Hospital
Name [1] 286801 0
Suez Canal University Hospital
Country [1] 286801 0
Egypt
Primary sponsor type
Hospital
Name
suez canal university hospital
Address
Suez Canal University Hospital
Four KM Road
box 3324
Ismailia
Egypt
Country
Egypt
Secondary sponsor category [1] 285592 0
None
Name [1] 285592 0
None
Address [1] 285592 0
None
Country [1] 285592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288869 0
Suez Canal University Hospital Ethics Committe.
Ethics committee address [1] 288869 0
Ethics committee country [1] 288869 0
Egypt
Date submitted for ethics approval [1] 288869 0
01/09/2009
Approval date [1] 288869 0
10/02/2010
Ethics approval number [1] 288869 0

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

Contacts
Principal investigator
Name 38138 0
A/Prof ehab ghoneim
Address 38138 0
el tammem street
borg el haramen, 6TH floor
Box5643
portfoad
portsaid
Country 38138 0
Egypt
Phone 38138 0
+201223639848
Fax 38138 0
+2066308822
Email 38138 0
ehabghoneim@hotmail.com
Contact person for public queries
Name 38139 0
ehab ghoneim
Address 38139 0
el tammem street
borg el haramen , 6TH floor
Box5643
portfoad
portsaid
Country 38139 0
Egypt
Phone 38139 0
+201223639848
Fax 38139 0
+2066308822
Email 38139 0
ehabghoneim@hotmail.com
Contact person for scientific queries
Name 38140 0
ehab ghoneim
Address 38140 0
el tammem street
borg el haramen, 6TH floor
Box564
portfoad
portsaid
Country 38140 0
Egypt
Phone 38140 0
+201223639848
Fax 38140 0
+2066308822
Email 38140 0
ehabghoneim@hotmail.com

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.