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Trial registered on ANZCTR


Registration number
ACTRN12616000853448
Ethics application status
Approved
Date submitted
20/06/2016
Date registered
29/06/2016
Date last updated
29/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central Australian Diabetic Maculopathy Study: Treatment Patterns and Outcomes
Scientific title
The Central Australian Diabetic Maculopathy Study: Visual Acuity Outcomes of Laser +/- Intravitreal anti-VEGF Injections
Secondary ID [1] 289471 0
NHMRC and FHF Centre for Research Excellence (CRE) in Diabetic Retinopathy App 1079864
Universal Trial Number (UTN)
Trial acronym
CADMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic maculopathy 299152 0
Condition category
Condition code
Eye 299168 299168 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 299169 299169 0 0
Diabetes
Public Health 299170 299170 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure arm = When lasers were found ineffective, anti-VEGFs (0.05ml avastin or lucentis) were administered on an as required basis as per standard care, and were not prescribed as part of this study.
Laser treatment parameters were administered at the discretion of the treating clinician as per standard care.
Anti VEGF drugs used– avastin or lucentis
1. Intravitreal Bevacizumab (Avastin) 1.25mg/0.05ml administered every 4 to 6 weeks initially or as required
2. Intravitreal Ranibizumab (Lucentis) 0.5mg/0.05ml administered every 4 to 6 weeks initially or as required
Ophthalmologist (TH) and Head of Department delivered the treatment/intervention as a day procedure in the Ophthalmology Department of the Alice Springs Hospital and its remote affiliate hospitals
Mode of delivery for injections was face-to-face service provision
This is an observational study where patients were followed up based on the severity of disease. The following time frames were usually followed:
Clinically significant macular edema – every 4-6 weeks until resolved
Non-proliferative Diabetic retinopathy (mild) – once a year
Non-proliferative Diabetic retinopathy (moderate) – Twice/year
Non-proliferative Diabetic retinopathy (severe) – every 4-6 months
Pre-proliferate Diabetic retinopathy – Every 3-months
Adherence to supplementary injections following laser treatment for progression of sight-threatening diabetic maculopathy was tracked from clinical file audits between the years 2001 and 2013. The duration of the follow-up period for this study for each participant was until stabilisation or improvement of retinopathy symptoms or features, whichever occurred first.
Intervention code [1] 295054 0
Not applicable
Comparator / control treatment
Arm 1 = Active Control/Comparator Arm = Laser(s) for the treatment of sight-threatening diabetic maculopathy. Laser therapy for diabetic maculopathy was applied on an as-needed basis upon review as per standard care.
Mode of delivery for laser treatment was face-to-face service provision.
The duration of the follow-up period for this study for each participant was until stabilisation or improvement of retinopathy symptoms, whichever occurred first.
Control group
Active

Outcomes
Primary outcome [1] 298653 0
Change in visual acuity level in logMAR letters
Timepoint [1] 298653 0
Last patient follow-up visit during audit period
Secondary outcome [1] 324859 0
N/A
Timepoint [1] 324859 0
N/A

Eligibility
Key inclusion criteria
Inclusion criteria were as follows: diabetic retinopathy patients receiving focal or macular photocoagulation at Alice Springs Hospital and/or Tennant Creek Hospital and those receiving treatment during outreach visits to remote communities. Patients were included in the study irrespective of racial background, age, location, co-morbidities and cataract status.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient data were excluded from study for the following reasons:
1. Deceased patients whose files were not accessible as those files were transferred to Iron Mountain (a repository for medical records of deceased patients) in Darwin for storage.
2. Patients whose HRN or DOB or Names did not exist in the hospital system, and despite best efforts remained unidentifiable
3. Patients receiving laser photocoagulation for other visual problems un-related to diabetic retinopathy
4. Patients whose files were lost or had no follow up after the first injection to analyze the treatment effect

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics; Between groups analysis both univariate and multivariate [adjusted for potential confounders].
All available treatment data were collected over the audit period, so a sample size was not calculated in advance of the audit. A post-hoc power calculation will be provided.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 5989 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [2] 5990 0
Tennant Creek Hospital - Tennant Creek

Funding & Sponsors
Funding source category [1] 293835 0
Charities/Societies/Foundations
Name [1] 293835 0
Fred Hollows Foundation
Address [1] 293835 0
52 Barry St. Carlton VIC 3053 AUSTRALIA
Country [1] 293835 0
Australia
Primary sponsor type
Hospital
Name
Alice Springs Hospital
Address
Gap Road, Alice Springs, Northern Territory, 0870
Country
Australia
Secondary sponsor category [1] 292667 0
Other Collaborative groups
Name [1] 292667 0
NHMRC and FHF Centre for Research Excellence (CRE) in Diabetic Retinopathy
Address [1] 292667 0
NHMRC Clinical Trials Centre, the University of Sydney
OFFICE: Medical Foundation Building Level 6
92–94 Parramatta Road, Camperdown NSW 2050
MAIL:Locked bag 77, Camperdown NSW 1450, Australia
Country [1] 292667 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295263 0
Central Australian Human Research Ethics Committee [CAHREC]
Ethics committee address [1] 295263 0
PO Box 4066 Alice Springs NT 0871
Ethics committee country [1] 295263 0
Australia
Date submitted for ethics approval [1] 295263 0
18/04/2013
Approval date [1] 295263 0
23/04/2013
Ethics approval number [1] 295263 0
HREC-13-145

Summary
Brief summary
Macular oedema (swelling of the central retina) is the commonest cause of visual loss in people with diabetes. Monthly injections of Anti VEGF are superior to conventional laser treatment when there is moderate visual loss from central macular oedema. However, monthly injections are less practical in central Australia and laser may be more effective than injections in many common clinical scenarios. Our pilot audit showed that results from laser in central Australia were equivalent to some of the original published cohorts of laser treatment. This study planned to audit results of laser treatment for diabetic maculopathy in central Australia over a longer period, and identify scenarios where laser remains an effective and affordable option in the treatment of diabetic maculopathy
Trial website
Trial related presentations / publications
Pavani Kurra, Laima Brazionis, Jesse Gale, Katie Chen, Stewart Lake, Tim Henderson. Central Australian Diabetic maculopathy Study. Presented at 44th RANZCO annual scientific conference. November 2015.
Abstract presented in clinical and experimental ophthalmology 43:61-62. October 2015.
Public notes

Contacts
Principal investigator
Name 66714 0
Dr Tim Henderson
Address 66714 0
Alice Springs Hospital
Gap Road, Alice Springs, Northern territory 0871
Country 66714 0
Australia
Phone 66714 0
+61 8 895 19180
Fax 66714 0
Email 66714 0
Tim.Henderson@nt.gov.au
Contact person for public queries
Name 66715 0
Dr Tim Henderson
Address 66715 0
Alice Springs Hospital
Gap Road, Alice Springs, Northern territory 0871
Country 66715 0
Australia
Phone 66715 0
+61 8 895 19180
Fax 66715 0
Email 66715 0
Tim.Henderson@nt.gov.au
Contact person for scientific queries
Name 66716 0
Dr Tim Henderson
Address 66716 0
Alice Springs Hospital
Gap Road, Alice Springs, Northern territory 0871
Country 66716 0
Australia
Phone 66716 0
+61 8 895 19180
Fax 66716 0
Email 66716 0
Tim.Henderson@nt.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary