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Laser Intervention in Early Age-Related Macular Degeneration Study (LEAD)

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ClinicalTrials.gov Identifier: NCT01790802
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Center for Eye Research Australia

Tracking Information
First Submitted Date  ICMJE February 12, 2013
First Posted Date  ICMJE February 13, 2013
Last Update Posted Date July 6, 2018
Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2013)
progression to advanced Age-related Macular Degeneration (AMD) in the treated eye [ Time Frame: 36 months ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
progression to advanced AMD in the treated eye [ Time Frame: 36 months ]
rate of progression to advanced AMD, either CNV, GA or preclinical atrophy, in the study eye of treatment group compared to the sham procedure group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
progression to advanced AMD in the untreated eye [ Time Frame: 36 months ]
rate of progression to advanced AMD, CNV, GA or preclinical atrophy in the fellow (untreated) eye
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 12, 2013)
  • reversal of early clinical indicators of AMD [ Time Frame: 36 months ]
    reversal of early clinical indicators of AMD (drusen area)
  • Improvements in visual acuity [ Time Frame: 36 months ]
    improvement in VA
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Laser Intervention in Early Age-Related Macular Degeneration Study
Official Title  ICMJE A Multi-centre, Randomized Trial Into the Safety and Efficacy of Nanosecond Microsurgical Laser Intervention in Early Age-related Macular Degeneration
Brief Summary The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the progression to advanced age-related macular degeneration.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE Device: 2RT nanosecond laser
active laser therapy
Study Arms  ICMJE
  • 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.
    Intervention: Device: 2RT nanosecond laser
  • 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.
    Intervention: Device: 2RT nanosecond laser
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2016)
292
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2013)
250
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01790802
Other Study ID Numbers  ICMJE CERA201201
ACTRN12612000704897 ( Registry Identifier: ANZCTR )
CTN Number130/2012 ( Other Identifier: TGA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Center for Eye Research Australia
Study Sponsor  ICMJE Center for Eye Research Australia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robyn H Guymer, PhD, FRANZCO Deputy Director CERA
PRS Account Center for Eye Research Australia
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP