ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Eye

Diseases / disorders of the eye

Metabolic and Endocrine

Diabetes

Public Health

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]

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]

Change in visual acuity level in logMAR letters

Timepoint [1]

Last patient follow-up visit during audit period

Secondary outcome [1]

N/A

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

19/05/2014

Date of last participant enrolment

Anticipated

Actual

30/06/2014

Date of last data collection

Anticipated

Actual

30/06/2014

Sample size

Target

300

Accrual to date

Final

352

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Alice Springs Hospital - Alice Springs

Recruitment hospital [2]

Tennant Creek Hospital - Tennant Creek

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Fred Hollows Foundation

Address [1]

52 Barry St. Carlton VIC 3053 AUSTRALIA

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alice Springs Hospital

Address

Gap Road, Alice Springs, Northern Territory, 0870

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

NHMRC and FHF Centre for Research Excellence (CRE) in Diabetic Retinopathy

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Australian Human Research Ethics Committee [CAHREC]

Ethics committee address [1]

PO Box 4066 Alice Springs NT 0871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/04/2013

Approval date [1]

23/04/2013

Ethics approval number [1]

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

Dr Tim Henderson

Address

Alice Springs Hospital
Gap Road, Alice Springs, Northern territory 0871

Country

Australia

Phone

+61 8 895 19180

Fax

Tim.Henderson@nt.gov.au

Contact person for public queries

Name

Tim Henderson

Address

Alice Springs Hospital
Gap Road, Alice Springs, Northern territory 0871

Country

Australia

Phone

+61 8 895 19180

Fax

Tim.Henderson@nt.gov.au

Contact person for scientific queries

Name

Tim Henderson

Address

Alice Springs Hospital
Gap Road, Alice Springs, Northern territory 0871

Country

Australia

Phone

+61 8 895 19180

Fax

Tim.Henderson@nt.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Visual Outcomes in the Management of Diabetic Maculopathy in Central Australia.	2020	https://dx.doi.org/10.1080/09286586.2020.1730909

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically