Overview

Status:Not yet recruiting
Keywords:Age-related macular degeneration , Laser treatment
IRB Number:00057816
Specialty:Ophthalmology
Sub Specialty:Retinal Diseases

Brief Summary

The LEAD study is a multi-center, double-blind, randomized, sham-procedure controlled, exploratory medical device clinical investigation, designed to better understand a nanosecond laser microsurgical intervention as a treatment for early age-related macular degeneration.  The study will also provide information on visual function measures as predictors for development of, and progression to, advanced AMD.

The primary objective is to ascertain whether nanosecond laser (2RT) therapy slows the progression to advanced AMD as measured by the proportion of early high-risk patients who progress to advanced AMD in the treated eye compared to the proportion who progress with sham laser therapy at 36 months from treatment.

Secondary objectives include evaluation of:

(1) Progression rate in the non-treated fellow eyes of the 2RT laser treatment group as compared to sham laser therapy

(2) Clinical indicators of AMD, including drusen area, compared between the treatment and sham groups.

Principle Investigator: Albert Vitale
Principle Department: Ophthalmology-Services
Co Investigator: Gregory Hageman
Co Investigator: Paul Bernstein
Co Investigator: Mary Elizabeth Hartnett
Co Investigator: Mike Teske

Contact Information

Name:Susan Allman
Phone:801-581-5142
Email:susan.allman@hsc.utah.edu

Inclusion Criteria

5.2 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 (bilateral large drusen) within an inner macular zone (a circle with a radius of 1500 microns centered on the fovea).
  • 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 Center.
  • 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

5.3 Exclusion Criteria

  • Any evidence of definite geographic atrophy within the macula (a circle with a radius of 3000 microns centered 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 vessels
  • 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
  • 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 atypical drusen.
  • 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., history of the diagnosis 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).24