Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001436369
Ethics application status
Approved
Date submitted
9/08/2017
Date registered
10/10/2017
Date last updated
24/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anti-VEGF treatment associated with laser photocoagulation in patients with macular edema due to branch vein occlusion
Scientific title
Efficacy of bevacizumab and laser photocoagulation for preventing the recurrence of macular edema due to branch vein occlusion.
Secondary ID [1] 292621 0
None
Universal Trial Number (UTN)
u1111-12005271
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema due to Branch Vein Occlusion 304309 0
Condition category
Condition code
Eye 303663 303663 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with macular edema due to branch vein retina occlusion (BRVO) were included. Complete ophthalmological examination was performed at baseline, including optical coherence tomography (OCT) and fluorescein angiography (FA). Enrolled patients were seen monthly up to the sixth month. Patients were treated with 1.25 mg intravitreous bevacizumab up to six injections. Best corrected visual acuity (BCVA) and OCT were measured in each visit. After the third injection, monthly, if the BCVA reached a plateau (same measurement of visit 3) or achieved 20/20 and there was no foveal OCT fluid, the injections were withheld and laser was applied at the same visit (once only). The type of laser is the argon laser. Macular photocoagulation settings were 50 to 100 um spot size, 50 to 100 ms pulse duration, and power titrated to achieve mild burn intensities. Patient was then followed monthly with BCVA and OCT. If after the third injection the patient did not reach the visual acuity (VA) plateau and/or had foveal fluid on OCT, the injections were continued until reaching the plateau or VA 20/20 or up to the maximum of 6 injections monthly. Retreatment criteria were: central macular thickness (CMT) > 300 microns with presence of foveal fluid and/or loss of 10 or more letters BCVA. If retinal neovascularization developed, laser photocoagulation would be applied.
Intervention code [1] 298839 0
Treatment: Drugs
Intervention code [2] 298842 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303026 0
Proportion of participants with recurrence of macular edema following maximal visual acuity stabilisation, assessed by best corrected visual acuity and optical coherence tomography (OCT).
Timepoint [1] 303026 0
12 months post enrolment
Secondary outcome [1] 337718 0
Number of bevacizumab injections administered to each patient.
Timepoint [1] 337718 0
12 months post enrolment

Eligibility
Key inclusion criteria
inclusion criteria: BRVO less than or equal to 12 months; best corrected visual acuity (BCVA) > 20/320 and < 20/40; all participants must have macular edema.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Main exclusion criteria: previous intravitreous drugs or macular laser treatment, macular surgery, cataract extraction in the previous 6 months, macular edema due to other causes.

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 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/05/2016
Date of last participant enrolment
Anticipated
Actual
13/02/2017
Date of last data collection
Anticipated
Actual
13/03/2018
Sample size
Target
15
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 9138 0
Brazil
State/province [1] 9138 0
São Paulo

Funding & Sponsors
Funding source category [1] 297249 0
Hospital
Name [1] 297249 0
Hospital Oftalmológico de Sorocaba
Country [1] 297249 0
Brazil
Primary sponsor type
Hospital
Name
Hospital Oftalmológico de Sorocaba
Address
Rua Nabek Shiroma, 210
Jardim Emilia
Sorocaba - São Paulo
CEP 18031-060
Country
Brazil
Secondary sponsor category [1] 296222 0
None
Name [1] 296222 0
Address [1] 296222 0
Country [1] 296222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298369 0
Ethics committee address [1] 298369 0
Ethics committee country [1] 298369 0
Brazil
Date submitted for ethics approval [1] 298369 0
Approval date [1] 298369 0
01/01/2016
Ethics approval number [1] 298369 0
CAAE:50931115.4.0000.0088

Summary
Brief summary
Purpose: To evaluate the use of up to six monthly treatments of anti-angiogenesis therapy followed by laser photocoagulation reduces the recurrence rate of macular edema secondary to branch retinal vein occlusion (BRVO) after maximal visual acuity (VA) stabilization.

Methods: patients with macular edema due to BRVO were included. Main inclusion criteria: BRVO less than or equal to 12 months; best corrected visual acuity (BCVA) > 20/320 and < 20/40. Main exclusion criteria: previous intravitreous drugs or macular laser treatment, macular surgery, cataract extraction in the previous 6 months, macular edema due to other causes.
Complete ophthalmological examination was performed at baseline, including optical coherence tomography (OCT) and fluorescein angiography (FA). Enrolled patients were seen monthly up to the sixth month. Patients were treated with 1.25 mg intravitreous bevacizumab up to six injections. BCVA and OCT were measured in each visit. After the third injection, if the BCVA reached a plateau (same measurement of visit 3) or achieved 20/20 and there was no foveal OCT fluid, the injections were withheld and laser was applied at the same visit. Patient was then followed monthly with BCVA and OCT. If after the third injection the patient did not reach the VA plateau and/or had foveal fluid on OCT, the injections were continued until reaching the plateau or VA 20/20 or up to the maximum of 6 injections. Retreatment criteria were: central macular thickness (CMT) > 300 microns with presence of foveal fluid and/or loss of 10 or more letters BCVA. If retinal neovascularization developed, laser photocoagulation would be applied. This study was approved by Ethics Committee of the Institution.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76850 0
Dr Arnaldo F. Bordon
Address 76850 0
Hospital Oftalmológico de Sorocaba
Rua Na bek Shiroma, 210
Jardim Emilia
Sorocaba - São Paulo
Cep 18031-060
Country 76850 0
Brazil
Phone 76850 0
+551532127000
Fax 76850 0
Email 76850 0
afbordon@terra.com.br
Contact person for public queries
Name 76851 0
Dr Arnaldo F. Bordon
Address 76851 0
Hospital Oftalmológico de Sorocaba
Rua Na bek Shiroma, 210
Jardim Emilia
Sorocaba - São Paulo
Cep 18031-060
Country 76851 0
Brazil
Phone 76851 0
+551532127000
Fax 76851 0
Email 76851 0
afbordon@terra.com.br
Contact person for scientific queries
Name 76852 0
Dr Arnaldo F. Bordon
Address 76852 0
Hospital Oftalmológico de Sorocaba
Rua Na bek Shiroma, 210
Jardim Emilia
Sorocaba - São Paulo
Cep 18031-060
Country 76852 0
Brazil
Phone 76852 0
+551532127000
Fax 76852 0
Email 76852 0
afbordon@terra.com.br

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

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