Trial record 9 of 340 for:    macular degeneration | Open Studies

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

This study is currently recruiting participants.
Verified February 2013 by Center for Eye Research Australia
Sponsor:
Information provided by (Responsible Party):
Center for Eye Research Australia
ClinicalTrials.gov Identifier:
NCT01790802
First received: February 12, 2013
Last updated: February 24, 2013
Last verified: February 2013

February 12, 2013
February 24, 2013
November 2011
June 2017   (final data collection date for primary outcome measure)
progression to advanced Age-related Macular Degeneration (AMD) in the treated eye [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
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
progression to advanced AMD in the treated eye [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
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
Complete list of historical versions of study NCT01790802 on ClinicalTrials.gov Archive Site
progression to advanced AMD in the untreated eye [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
rate of progression to advanced AMD, CNV, GA or preclinical atrophy in the fellow (untreated) eye
Same as current
  • reversal of early clinical indicators of AMD [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    reversal of early clinical indicators of AMD (drusen area)
  • Improvements in visual acuity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    improvement in VA
Same as current
 
Laser Intervention in Early Age-Related Macular Degeneration Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Age-related Macular Degeneration
Device: 2RT nanosecond laser
active laser therapy
  • 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
    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.
    Intervention: Device: 2RT nanosecond laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
June 2017
June 2017   (final data collection date for primary outcome measure)

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).
Both
50 Years to 95 Years
No
Contact: Peter R Keller, PhD +61 3 9929 8110 peter.keller@unimelb.edu.au
Australia
 
NCT01790802
CERA201201, ACTRN12612000704897, CTN Number130/2012
Yes
Center for Eye Research Australia
Center for Eye Research Australia
Not Provided
Study Chair: Robyn H Guymer, PhD, FRANZCO Deputy Director CERA
Center for Eye Research Australia
February 2013

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