Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000267752
Ethics application status
Approved
Date submitted
9/08/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Date results information initially provided
14/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and efficacy of intra-vitreal bevacizumab combined with supra-choroidal triamcinolone in the treatment of central retinal vein occlusion.
Scientific title
The effect of treatment with intra-vitreal bevacizumab 0.05ml combined with supra-choroidal triamcinolone 0.05ml on macular thickness and visual acuity in central retinal vein occlusion patients.
Secondary ID [1] 304494 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central retinal vein occlusion 323014 0
Macular edema 325170 0
Condition category
Condition code
Eye 320577 320577 0 0
Diseases / disorders of the eye
Eye 322576 322576 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In our study we will give intra-vitreal bevacizumab 0.05ml(1.25mg) combined with 0.05ml(2mg) of triamcinolone in supra-choroidal space to determine the outcome of central retinal vein occlusion in terms of decrease in macular edema via ocular coherence tomography and increase in visual acuity by assessing visual acuity via snellen chart. Each injection will be given monthly like 1 injection given at presentation then other will be given after 1 month of that and 3rd injection after 1 month of the 2nd injection. The patient will be followed on monthly basis for three consecutive months and his macular thickness, visual acuity and intra-ocular pressure will be recorded monthly.
Intervention code [1] 321282 0
Treatment: Drugs
Comparator / control treatment
There is no controlled group in our study as it is a self controlled study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328401 0
Macular thickness (Measured with the help of ocular coherence tomography)
Timepoint [1] 328401 0
Will be assessed at presentation and then after 1 month of 1st injection, then after 1 month of 2nd injection and then after 1 month of 3rd injection.
Secondary outcome [1] 398905 0
Visual acuity, assessed with LogMAR chart.
Timepoint [1] 398905 0
will be assessed at presentation and then after 1 month of 1st injection , then after 1 month of 2nd injection and then after 1 month of 3rd injection. (so this means monthly for three consecutive months )

Eligibility
Key inclusion criteria
1, All those patients diagnosed with central retinal vein occlusion
2, Either gender (male/female)
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1, All those patients having poor compliance and follow up
2, All Known glaucomatous or glaucoma suspected patients
3, Eyes with opaque media in which fundus assessment was not possible like, dense cataracts, corneal opacity, vitreous bleed etc.
4, Eyes with prior lasers or injections done.
5, Eyes with complications like neo-vessels on disc and else-where in fundus and anterior segment neo-vessels.
6, Eyes with active inflammation or infection like conjunctivitis etc.

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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/07/2021
Date of last participant enrolment
Anticipated
Actual
29/09/2021
Date of last data collection
Anticipated
Actual
30/12/2021
Sample size
Target
34
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 24025 0
Pakistan
State/province [1] 24025 0
Khyber Pakhtunkhwa (KPK)

Funding & Sponsors
Funding source category [1] 308856 0
Self funded/Unfunded
Name [1] 308856 0
Salahuddin (primary author)
Country [1] 308856 0
Pakistan
Primary sponsor type
Individual
Name
Salahuddin
Address
Hayatabad Medical Complex, Hayatabad, phase 4, Peshawar, Khyber Pakhtunkhwa, 25000,Pakistan.
Country
Pakistan
Secondary sponsor category [1] 310335 0
None
Name [1] 310335 0
Address [1] 310335 0
Country [1] 310335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308765 0
Research And Ethical Committee of Hayatabad Medical complex Peshawar.
Ethics committee address [1] 308765 0
Hayatabad medical complex, phase 4, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan.
Ethics committee country [1] 308765 0
Pakistan
Date submitted for ethics approval [1] 308765 0
03/06/2021
Approval date [1] 308765 0
16/06/2021
Ethics approval number [1] 308765 0
464/HEC/B&PSC/2020

Summary
Brief summary
TITLE :
SAFETY AND EFFICACY OF INTRAVITREAL BEVACIZUMAB COMBINED WITH SUPRACHOROIDAL TRIAMCINOLONE IN THE TREATMENT OF CENTRAL RETINAL VEIN OCCLUSION
We have planned this study to determine the outcome of central retinal vein occlusion, in terms of decrease in macular edema and increase in visual acuity, after treatment with intravitreal Bevacizumab 0.05ml combined with supra-choroidal triamcinolone 0.05ml and also determines its safety in terms of intra-ocular pressure and infection.
OBJECTIVE:
To determine the safety and effectiveness of suprachoroidal triamcinolone 0.05ml in combination with intra-vitreal bevacizumab 0.05ml in eyes with central retinal vein occlusion.
HYPOTHESIS:
Suprachoroidal triamcinolone 0.05ml and intravitreal bevacizumab 0.05ml are both safe and effective when given in combination in the treatment of central retinal vein occlusion.

Our study will continue for six months because the patients enrolled in our study in the month of September will need follow up till the month of December, as we have to give total 3 injections, 1 injection of both bevacizumab and triamcinolone every month for three months, and follow them every month and to see the response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111806 0
Dr Salahuddin
Address 111806 0
Hayatabad Medical Complex, phase 4, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan.
Country 111806 0
Pakistan
Phone 111806 0
+920913349067574
Fax 111806 0
Email 111806 0
dr.salahuddin707@yahoo.com
Contact person for public queries
Name 111807 0
Dr Salahuddin
Address 111807 0
Hayatabad Medical Complex, phase 4, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan.
Country 111807 0
Pakistan
Phone 111807 0
+920913349067574
Fax 111807 0
Email 111807 0
dr.salahuddin707@yahoo.com
Contact person for scientific queries
Name 111808 0
Dr Salahuddin
Address 111808 0
Hayatabad Medical Complex, phase 4, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan.
Country 111808 0
Pakistan
Phone 111808 0
+920913349067574
Fax 111808 0
Email 111808 0
dr.salahuddin707@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data about dates of injections and dates of follow up and status of the patients eyes on follow up, will be available in proformas and documentation form.
When will data be available (start and end dates)?
Data will be safe with me and will be shared on request through email, if some one wants.
Dates: 1st January 2022 to 31st December 2024.
Available to whom?
Will be available for any related person to the study and profession of ophthalmology.
Available for what types of analyses?
Will be available for getting help for their study or for checking my data authenticity.
How or where can data be obtained?
Data can be obtained on request through my email address.
Email address: dr.salahuddin@yahoo.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12803Ethical approval  dr.salahuddin707@yahoo.com
14109Study protocol  dr.salahuddin707@yahoo.com



Results publications and other study-related documents

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