Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001056280
Ethics application status
Approved
Date submitted
4/12/2009
Date registered
10/12/2009
Date last updated
10/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Retinal regeneration Laser Treatment in Early Age-related Maculopathy
Scientific title
Evaluation of the effect of retinal regeneration laser therapy on visual function and clinical fundus status in Early Age-related Maculopathy(AMD)
Secondary ID [1] 1180 0
none
Universal Trial Number (UTN)
Trial acronym
2RTEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Age related Maculopathy 252345 0
Condition category
Condition code
Eye 252536 252536 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves the use of a new laser called the 2RT retinal Regeneration Therapy laser. The laser will be applied once only to one eye. It will be fired approximately 12 times near the arcades of the retina. It utilises low energy and extremely short nanosecond duration laser to produce very limited effects.
Intervention code [1] 255658 0
Treatment: Devices
Comparator / control treatment
The other eye will be the control in this trial as only one eye recieves treatment.
Control group
Active

Outcomes
Primary outcome [1] 253418 0
Reduction in the appearance of drusen in a clinical evaluation.
Timepoint [1] 253418 0
Clinical evaluation will be conducted at baseline, 1 month, 3 month, 6 month, 9 month, 12 month
Primary outcome [2] 253419 0
An increase in visual functions of the treated eye. Visual functions will be monitored by measuring patients dark adaptation, static test which involves measuring thershold assesments for isoluminant read and blue increments and flicker sensitivity of 4 and 14Hz. Their Photostress cone recovery will also be measured for improvement. 3 questionaires will also be administered
Timepoint [2] 253419 0
Visual functions will be measured at baseline, 1 month, 3 month, 6 month, 9 month and 12 month. The questionaires will only be administered at baseline and 12 month.
Secondary outcome [1] 262526 0
nil
Timepoint [1] 262526 0
nil

Eligibility
Key inclusion criteria
Bliateral multiple large drusen( >125 micron) and pigment changes.
Impaired dark adaptation in both eyes.
Vison equal to or better than 6/19.
Minimum age
45 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Advanced AMD.
Diabetic retinopathy.
Glaucomous changes.
Pathology which significantly compromises therapeutic or investigative access to the fundus fo the eye.
Intraocular surgery other than uncomplicated cataract surgery > 6 months.
History or evidence of previous retinal disorder or retinal laser treatment or intra-ocular inflammotory disease.
Other retianl or ocular disease or recent symptoms of wet AMD.
Known allergic hypersensitivity to fluorescein.
Active malignant diseases or other serious systemic diseases.

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)
The patient attends a screening visit to determine eligibility. A clinical exam of the retina is to confirm eligibility. Visual functions are also measured to assess the level of abnormality. If both criteria are fulfilled and the patient consents to partcipating in the study then the patient is enrolled. The eye which displays worse visual functions and/or appearance is selected as the study eye.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable as all patients receive treatement to one eye.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256136 0
Government body
Name [1] 256136 0
Innovation for Victoria's Science Agenda Investment Fund grants program
Country [1] 256136 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ellex
Address
82 gilbert street, Adelaide SA, 5000
Country
Australia
Secondary sponsor category [1] 251476 0
None
Name [1] 251476 0
Address [1] 251476 0
Country [1] 251476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258227 0
Human Research and Ethics committe Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 258227 0
32 Gisborne Street East Melbourne Vic 3002
Ethics committee country [1] 258227 0
Australia
Date submitted for ethics approval [1] 258227 0
Approval date [1] 258227 0
25/08/2008
Ethics approval number [1] 258227 0
08/853H

Summary
Brief summary
This is a clinical research study to trial a new laser treatment with the aim of slowing or partially reversing the progression Age Related Macular Degeneration (AMD), a disease which affects the retina and can ultimately lead to central vision blindness. Curently there is no treatment available for Early AMD. The study device is a laser which has been specially developed to treat retinal diseases and in this setting it is hoped it will target cells involved in the disease process and exhibit a wound healing effect which may lead to a delay or halt in the progression of AMD. The results of the laser will be monitored by asessing clinical markers and measuring visual functions.
Trial website
Not Applicable
Trial related presentations / publications
Not Applicable
Public notes

Contacts
Principal investigator
Name 30584 0
Address 30584 0
Country 30584 0
Phone 30584 0
Fax 30584 0
Email 30584 0
Contact person for public queries
Name 13831 0
Kate Brassington
Address 13831 0
Level 1, Royal Victorian Eye and Ear Hospital. 32 Gisborne Street East Melbourne Vic 3002
Country 13831 0
Australia
Phone 13831 0
+61 3 99298362
Fax 13831 0
Email 13831 0
kbra@unimelb.edu.au
Contact person for scientific queries
Name 4759 0
Professor Robyn Guymer
Address 4759 0
Level 1, Royal Victorian Eye and Ear Hospital. 32 Gisborne Street East Melbourne Vic 3002
Country 4759 0
Australia
Phone 4759 0
+61 3 99298393
Fax 4759 0
Email 4759 0
rhg@unimelb.edu.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
SourceTitleYear of PublicationDOI
EmbasePrognostic implications of imaging in atrophic macular degeneration and its use in clinical practice and clinical trial design.2016https://dx.doi.org/10.1111/ceo.12671
EmbaseNanosecond laser therapy reverses pathologic and molecular changes in age-related macular degeneration without retinal damage.2015https://dx.doi.org/10.1096/fj.14-262444
EmbaseNanosecond laser treatment for age-related macular degeneration does not induce focal vision loss or new vessel growth in the retina.2018https://dx.doi.org/10.1167/iovs.17-23098
EmbaseEffect of subthreshold nanosecond laser on retinal structure and function in intermediate age-related macular degeneration.2022https://dx.doi.org/10.1111/ceo.14018
Dimensions AIInter-device comparison of retinal sensitivity measurements: the CenterVue MAIA and the Nidek MP-12016https://doi.org/10.1111/ceo.12629
N.B. These documents automatically identified may not have been verified by the study sponsor.