ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000202268

Ethics application status

Approved

Date submitted

22/11/2017

Date registered

7/02/2018

Date last updated

17/12/2019

Date data sharing statement initially provided

18/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparing the effectiveness and safety of two treatments (OZURDEX® intravitreal implant versus Avastin®) for diabetic eye disease in adult Indigenous patients living in Western Australia.

Scientific title

A randomised active-controlled non-inferiority trial of OZURDEX® intravitreal implant versus Avastin® intravitreal injection in Indigenous patients with or at risk of diabetic macular oedema, at the time of or following cataract surgery. (The OASIS Study)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1204-9415

Trial acronym

OASIS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetic Macular Oedema

Condition category

Condition code

Eye

Diseases / disorders of the eye

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

0.7mg intravitreal dexamethasone implant (Ozurdex) administered by a consultant ophthalmologist, or an ophthalmology fellow under consultant supervision, in operating theatres at the time of cataract surgery for phakic participants. The injection will be performed after implantation of the intraocular lens for patients undergoing cataract surgery. The case duration is expected to be approximately 20 minutes in most cases.

For pseudophakic participants, injections will be performed in outpatient treatment facilities by the same clinical staff as above. The treatment duration is expected to be 5 minutes for most pseudophakic participants.

Followup will be offered monthly with retreatment as clinically indicated. The overall intervention period for this trial will be 12 months.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

1.25mg/0.05ml intravitreal Bevacizumab (Avastin) administered in operating theatres at the time of cataract surgery for phakic participants, and in outpatient treatment facilities for pseudophakic participants. Followup will be offered monthly with retreatment as clinically indicated. The overall intervention period for this trial will be 12 months.

Control group

Active

Outcomes

Primary outcome [1]

Mean change in Best Corrected Visual Acuity (BCVA).

Timepoint [1]

6 Months, 12 Months

Secondary outcome [1]

Mean change in Central Retinal Thickness (CRT) as measured by Optical Coherence Tomography (OCT).

Timepoint [1]

6 Months, 12 Months

Secondary outcome [2]

Number of intravitreal injections given (by review of medical records, for injections assigned for the purposes of this study).

Timepoint [2]

6 Months, 12 Months

Secondary outcome [3]

Number of participants requiring laser treatment (by review of medical records for the study eye).

Timepoint [3]

6 Months, 12 Months

Secondary outcome [4]

Adverse events. Known adverse effects specific to this drug include increased intra-ocular pressure (IOP) and posterior subcapsular cataract formation. IOP will be measured at each visit and treated as clinically indicated..

Timepoint [4]

12 Months

Eligibility

Key inclusion criteria

• Self-identifying Indigenous Australian.
• Adult aged 18 years and over.
• Diagnosis of diabetes mellitus (type 1 or 2).
• Best-corrected visual acuity (BCVA) of at best 6/9 to in the study eye.
• Pseudophakic – OR – phakic with significant lens opacity and scheduled to undergo
cataract surgery at the time of enrolment.
• Presence of any grade of diabetic retinopathy with:
A. Active DMO (phakic or pseudophakic patients): Centre-involving/threatening
DMO, as defined by clinical examination and OCT scan findings.
B. At risk of DMO (phakic patients only): Assessed as being at risk of post-operative
DMO based on clinical examination, OCT scan findings and investigator discretion.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Intervention in the study eye including:
- Intravitreal anti-VEGF injections within the last 6 weeks;
- Macular laser within the last 4 months;
- Intravitreal triamcinolone or triescence within the last 6 months; of time of first trial
treatment.
• History of open-angle glaucoma or steroid induced IOP elevation that required IOP-
lowering treatment or, IOP =25 (Goldmann applanation) on 2 consecutive clinic visits.
• Eyes with concurrent ocular pathology other than DMO causing visual loss.
• Women who are breastfeeding, confirmed as pregnant or planning on becoming
pregnant in the next 6-12 months.
• Participants for whom Ozurdex or Avastin treatment are contraindicated as per
Product Information:
- Active or suspected ocular/periocular infections including most viral diseases of
the cornea and conjunctiva, active epithelia herpes simplex keratitis (dendritic
keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
- Aphakic eyes with rupture of the posterior lens capsule.
- Eyes with anterior chamber intraocular lens and rupture of the posterior lens
capsule.
- Known angina, myocardial infarction, TIA or CVA in last 3 months.
- Known hypersensitivity to any components of these products

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

7/02/2017

Date of last participant enrolment

Anticipated

Actual

29/04/2019

Date of last data collection

Anticipated

29/04/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

ALLERGAN AUSTRALIA PTY LTD

Address [1]

Level 4
810 Pacific Highway
Gordon, NSW 2072
Australia

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

LIONS EYE INSTITUTE LTD

Address

2 Verdun St
Nedlands, WA 6009
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Western Australian Aboriginal Health Ethics Committee (WAAHEC)

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/10/2015

Approval date [1]

19/05/2017

Ethics approval number [1]

677

Summary

Brief summary

DMO is the most common cause of visual loss in people with diabetes. Regular injections with bevacizumab (Avastin), given as frequently as every month, remain the current standard of care for centre-involving DMO, but this regimen is impractical for many Indigenous patients. Limiting injections to 3-6 monthly with Ozurdex may be as effective as the currently used Avastin injections. 

The specific aim of the study is therefore to test the following hypothesis:
1. Ozurdex®  is a safe and non-inferior treatment to Avastin®  when administered during or following cataract surgery in Indigenous patients with/at risk of DMO.
2. Ozurdex ® requires fewer injections when compared with Avastin® in Indigenous patients with/at risk of DMO.

Trial website

Trial related presentations / publications

Public notes

Conditional Approval from WAAHEC was granted on 24/11/2015, with Final Approval granted on 19/05/2017. The small number of participants enrolled within this time period were subsequently disqualified and withdrawn from the trial, Participant enrolment recommenced  July 2017.

Contacts

Principal investigator

Name

Dr Hessom Razavi

Address

Lions Eye Institute
Retinal Pod
2 Verdun St
Nedlands WA 6009

Country

Australia

Phone

+61 8 6382 0544

Fax

+61 8 9381 0700

hessomrazavi@lei.org.au

Contact person for public queries

Name

Carly Fry

Address

Lions Outback Vision
2 Verdun Street
Nedlands WA 6009

Country

Australia

Phone

+61 8 9381 0802

Fax

+61 8 9381 0700

CarlyFry@lei.org.au

Contact person for scientific queries

Name

Hessom Razavi

Address

Lions Outback Vision
2 Verdun Street
Nedlands WA 6009

Country

Australia

Phone

+61 8 6382 0544

Fax

+61 8 9381 0700

HessomRazavi@lei.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To protect individual patient confidentiality.

What supporting documents are/will be available?

Doc. No.	Type	Email
6213	Study protocol	HessomRazavi@lei.org.au
6214	Informed consent form	HessomRazavi@lei.org.au
6215	Ethical approval	HessomRazavi@lei.org.au

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	Intravitreal dexamethasone versus bevacizumab in Aboriginal and Torres Strait Islander patients with diabetic macular oedema: The OASIS study (a randomised control trial).	2022	https://dx.doi.org/10.1111/ceo.14079

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

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