ClinicalTrials.gov

History of Changes for Study: NCT01790802
Laser Intervention in Early Age-Related Macular Degeneration Study (LEAD)
Latest version (submitted July 4, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 12, 2013 None (earliest Version on record)
2 February 24, 2013 Outcome Measures, Sponsor/Collaborators and Study Status
3 June 16, 2015 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Arms and Interventions and Conditions
4 February 17, 2016 Study Design and Study Status
5 August 14, 2017 Study Status
6 July 4, 2018 Recruitment Status, Study Status and Eligibility
Comparison Format:

Scroll up to access the controls

Study NCT01790802
Submitted Date:  February 12, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: CERA201201
Brief Title: Laser Intervention in Early Age-Related Macular Degeneration Study (LEAD)
Official Title: A Multi-centre, Randomized Trial Into the Safety and Efficacy of Nanosecond Microsurgical Laser Intervention in Early Age-related Macular Degeneration
Secondary IDs: ACTRN12612000704897 [Registry Identifier: ANZCTR]
CTN Number130/2012 [TGA]
Open or close this module Study Status
Record Verification: February 2013
Overall Status: Recruiting
Study Start: November 2011
Primary Completion: June 2017 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: February 12, 2013
First Submitted that
Met QC Criteria:
February 12, 2013
First Posted: February 13, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 12, 2013
Last Update Posted: February 13, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Center for Eye Research Australia
Responsible Party: Sponsor
Collaborators: National Health and Medical Research Council, Australia
Ellex R&D Ltd
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Age-related Macular Degeneration
Keywords: laser treatment, high risk, early age-related macular degeneration
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 250 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Device: 2RT nanosecond laser
active laser therapy
Sham Comparator: Sham laser procedure
To simulate laser application the maximum illumination button will be briefly pressed by the operating physician at each of the 12 locations described above where and when the laser would normally be applied. The laser remains in standby mode preventing accidental laser firing.
Device: 2RT nanosecond laser
active laser therapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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
Other Outcome Measures:
1. reversal of early clinical indicators of AMD
[ Time Frame: 36 months ]

reversal of early clinical indicators of AMD (drusen area)
2. Improvements in visual acuity
[ Time Frame: 36 months ]

improvement in VA
Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age: 95 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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, OCT and 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). Geographic atrophy is defined as an area of partial or complete depigmentation of the RPE in the fundus photographs that has at least 2 of the following 3 characteristics (i) roughly round or oval shape, (ii) sharp margins, and (iii) visibility of underlying large choroidal vessels25
  • 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; Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/or small retinal hemorrhages, without retinal thickening on OCT) Angioid streaks, Central serous choroidopathy, Optic atrophy, Epiretinal membrane involving the macula, Pigmentary abnormalities 0f the retina atypical of AMD (e.g., myopia, pattern dystrophy or chronic central serous retinopathy), Myopic crescent wider than 50% of the longest diameter of the optic disc, or closer than 1500 microns to the fovea, Macular hole or pseudohole, Retinal vein occlusion, active uveitis, presumed ocular histoplasmosis syndrome, Choroidal naevus within 2 DD of the fovea associated with depigmentation or overlying drusen, if these drusen are used to determine eligibility. Amblyopia in either eye even if BCVA is better than 6/12 (20/40).
  • 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 (Plaquinil), 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 (e.g., demonstrated field defect typical of glaucoma, history of, medical, surgical or laser intervention for the treatment of glaucoma, or disc/nerve fibre layer defects suggestive of 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).
Open or close this module Contacts/Locations
Central Contact Person: Peter R Keller, PhD
Telephone: +61 3 9929 8110
Email: peter.keller@unimelb.edu.au
Study Officials: Robyn H Guymer, PhD, FRANZCO
Study Chair
Deputy Director CERA
Locations: Australia, Victoria
Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital
[Recruiting]
East Melbourne, Victoria, Australia, 3002
Contact:Contact: Emily EA Caruso, B Orth & OphSc +61 3 9929 emily.caruso@unimelb.edu.au
Contact:Principal Investigator: Robyn H Guymer, MBBS, PhD, FRANZCO
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services