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Age-related Macular DegenerationLEADNCT01790802

Laser Intervention in Early Age-Related Macular Degeneration Study

A study testing 2RT nanosecond laser in people with Age-related Macular Degeneration, run by Center for Eye Research Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the progression to advanced age-related macular degeneration. Read more about this study

Who is it for?
Ages 50 to 95 years
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
2RT nanosecond laser
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
292 participants
Where
1 siteAustralia
Study dates
Nov 2011to 1 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital

    East Melbourne, Victoria, 3002

Other trials in Australia

About this study

Official title: A Multi-centre, Randomized Trial Into the Safety and Efficacy of Nanosecond Microsurgical Laser Intervention in Early Age-related Macular Degeneration

The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the progression to advanced age-related macular degeneration.

Read the detailed description

LEAD is a patient and assessor masked, multi-centre randomized controlled exploratory medical device clinical investigation of 240 participants (1:1 active to shame laser procedure) designed to assess the effectiveness of nanosecond laser treatment of patients with early high-risk AMD.

No less than 240 participants will be randomized into either active laser treatment or sham laser procedure groups at a ratio of 1:1. Patient eligibility based on ocular inclusion criteria will be evaluated using measures of vision, fundus photography, OCT imaging, and macular integrity (MAIA) performed during the qualifying period. Fundus images and MAIA results will be sent to a coordinating centre where these will be reviewed to confirm eligibility based on lesion attributes and the criteria specified in the protocol. Following confirmation of eligibility by the coordinating centre, participants whom satisfy all the inclusion and exclusion criteria can be randomized. Allocation to treatment group will be stratified by smoking status. All participants will receive either active laser treatment or sham laser procedure at the treatment visit and be assessed for retreatment on a semi-annual basis. All participants will be contacted by telephone at 1 week and present for clinical examination visits at 1, 6, 12, 18, 24, 30 and 36 months.

Being tested
2RT nanosecond laser
Keywords
laser treatment, high risk, early AMD
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2RT nanosecond laserDevice

    active laser therapy

Study groups in NCT01790802
Study groupRoleWhat they receive
Active laserExperimentalTwelve 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.
Receives: Device: 2RT nanosecond laser
Sham laser procedureSham comparatorThe 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.
Receives: Device: 2RT nanosecond laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression to advanced Age-related Macular Degeneration (AMD) in the treated eye

    rate of progression to advanced AMD, either Choroidal Neovascularization (CNV), Geographic Atrophy (GA) or preclinical atrophy, in the study eye of treatment group compared to the sham procedure group

    Measured: 36 months

Secondary outcomes (1)

  1. progression to advanced AMD in the untreated eye

    rate of progression to advanced AMD, CNV, GA or preclinical atrophy in the fellow (untreated) eye

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study startNov 2011
  3. Primary completion1 May 2018
  4. Study completion1 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01790802
Sponsor's protocol ID
CERA201201
Other IDs
ACTRN12612000704897, CTN Number130/2012
Acronym
LEAD
Status last verified
Jul 2018
First submitted
12 Feb 2013
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Riedl S, Schmidt-Erfurth U, Rivail A, Birner K, Mai J, Vogl WD, Wu Z, Guymer RH, Bogunovic H, Reiter GS. Sequence of Morphological Changes Preceding Atrophy in Intermediate AMD Using Deep Learning. Invest Ophthalmol Vis Sci. 2024 Jul 1;65(8):30. doi: 10.1167/iovs.65.8.30.

    PubMed 39028907

  • Goh KL, Wintergerst MWM, Abbott CJ, Hadoux X, Jannaud M, Kumar H, Hodgson LAB, Guzman G, Janzen S, van Wijngaarden P, Finger RP, Guymer RH, Wu Z. HYPERREFLECTIVE FOCI NOT SEEN AS HYPERPIGMENTARY ABNORMALITIES ON COLOR FUNDUS PHOTOGRAPHS IN AGE-RELATED MACULAR DEGENERATION. Retina. 2024 Feb 1;44(2):214-221. doi: 10.1097/IAE.0000000000003958.

    PubMed 37831941

  • Wu Z, Luu CD, Hodgson LAB, Caruso E, Chen FK, Chakravarthy U, Arnold JJ, Heriot WJ, Runciman J, Guymer RH; LEAD Study Group. USING MICROPERIMETRY AND LOW-LUMINANCE VISUAL ACUITY TO DETECT THE ONSET OF LATE AGE-RELATED MACULAR DEGENERATION: A LEAD Study Report. Retina. 2021 May 1;41(5):1094-1101. doi: 10.1097/IAE.0000000000002982.

    PubMed 33009222

Questions about this trial

What is this clinical trial studying?

A study testing 2RT nanosecond laser in people with Age-related Macular Degeneration, run by Center for Eye Research Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression to advanced Age-related Macular Degeneration (AMD) in the treated eye (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01790802, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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