Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01790802




Registration number
NCT01790802
Ethics application status
Date submitted
12/02/2013
Date registered
13/02/2013
Date last updated
6/07/2018

Titles & IDs
Public title
Laser Intervention in Early Age-Related Macular Degeneration Study
Scientific title
A Multi-centre, Randomized Trial Into the Safety and Efficacy of Nanosecond Microsurgical Laser Intervention in Early Age-related Macular Degeneration
Secondary ID [1] 0 0
ACTRN12612000704897
Secondary ID [2] 0 0
CERA201201
Universal Trial Number (UTN)
Trial acronym
LEAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 2RT nanosecond laser

Experimental: Active laser - Twelve 2RT nanosecond laser shots in two arcs of 6 shots superiorly and 6 shots inferiorly, inside the retinal vascular arcades at an approximate distance from the fovea of 3000 microns, with approximately one laser spot diameter between them.

Sham comparator: Sham laser procedure - The maximum illumination button on hte 2RT laser will be briefly pressed by the operating physician at each of the 12 locations where and when the laser would normally be applied. The laser remains in standby mode preventing accidental laser firing.


Treatment: Devices: 2RT nanosecond laser
active laser therapy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
progression to advanced Age-related Macular Degeneration (AMD) in the treated eye
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
progression to advanced AMD in the untreated eye
Timepoint [1] 0 0
36 months

Eligibility
Key inclusion criteria
* Males or females from 50 to 95 years of age at the time of consent
* Best corrected visual acuity (BCVA) of 6/12 (20/40) or better in each eye.
* Bilateral high-risk early AMD: At least one druse =125um within an inner macular zone (a circle with a radius of 1500 microns centred on the fovea) with or without pigment.
* A MAIA static threshold sensitivity less than 25 dB at any point, within a customized grid, as measured using a Macular Integrity Assessment (MAIA) device), at the same location of the one eye on two separate occasions.
* Pupil dilation of a least 5 mm in each eye
* Fundus photographs, optical coherence tomography (OCT) and fundus autofluorescence (FAF) images of adequate quality as assessed by the LEAD Image Reading Centre.
* Ability and willingness to consent, and be randomized, to the 2RT active or sham laser treatment, and all qualification and follow-up phases of the study.
Minimum age
50 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any evidence of definite geographic atrophy within the macula (a circle with a radius of 3000 microns centred on the fovea).
* Any black (hypofluorescent) area of FAF consistent with GA (roughly round or oval shape, sharp margins), and corroborated on colour photography as a patch of hypopigmentation.
* Any evidence of 'preclinical atrophy' as determined on OCT: loss of the outer retina (RPE and photoreceptors on the cube scan (Spectralis OCT) (49 horizontal B scans, 120 µm apart over a 20 x 20 degree scan). This covers approximately 6 x 6 mm in an emmetropic eye (N.B., peri-papillary atrophy (PPA) further than 1500 microns from the fovea is allowed).
* Current CNV, or past evidence of CNV in either eye.
* Any other experimental treatment for AMD, excluding dietary supplements, received in the past 12 months or thought likely to chronically change the course of the participant's retinal disease.
* Any OCT showing evidence of intraretinal fluid, or subretinal fluid for which CNV cannot be excluded as a cause.
* A subfoveal pigment epithelial detachment/drusenoid detachment greater than 1000 microns in diameter.
* Other macular disease with subretinal deposits not typical of AMD, e.g., Malattia Leventinese, Sorsby fundus dystrophy, Alports syndrome
* Ocular disease in either eye, other than AMD, which significantly compromises the ability to treat or visualize the fundus or would compromise the ability to assess any effect following laser application including;
* Known allergic hypersensitivity to fluorescein.
* Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD.
* Requirement for any systemic or ocular medication known to be toxic to the retina, such as: Deferoxamine, Chloroquine/Hydroxychloroquine (Plaquenil), Chlorpromazine, Phenothiazines, Ethambutol
* Any serious systemic disease that will preclude a 3 year survival and regular attendance for follow up.
* Sensitivity to contact lens application.
* Any condition that would make adherence to the examination schedule for 3 years difficult or unlikely.
* Any history of prior laser surgery to the retina.
* Intraocular pressures of 26mm Hg or higher or if there is some reason to believe the participant may have glaucoma
* Significant cataract: Nuclear cataract grade 2 or 3, cortical cataract Grade 2 or 3 or posterior subcapsular cataract Grade 2 or 3, by Simplified Cataract Grading System (WHO Cataract Grading Group).

Study design
Purpose of the study
Prevention
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
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Center for Eye Research Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn H Guymer, PhD, FRANZCO
Address 0 0
Deputy Director CERA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01790802