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

Not Applicable

Completed

• Conditions: Age related Macular Degeneration; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12612000704897
• Lead Sponsor: Centre for Eye Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Age 50 years and older, and less than 95 years. Best Corrected Visual Acuity (BCVA) of 6/12 (20/40) or better in each eye. Bilateral high-risk early AMD (AREDS Simplified Severity Scale, at least 2 risk factors) within an inner macular zone (a circle with a radius of 1500 microns centered on the fovea). A threshold sensitivity less than 25 dB at any point, within a customised 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 5mm or more 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 randomised, to 2RT or sham laser treatment, and all qualification and follow-up phases of the study.

Exclusion Criteria

Any imaged retinal sign suggestive of geographic atrophy within the macula (a circle with a radius of 3000 microns centred on the fovea). Peri-papillary atrophy further than 1500 microns from the fovea is allowed.
CNV, or past treatment for 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 image showing evidence of intraretinal fluid (cysts), 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 in either eye.
Ocular disease in either eye, other than AMD, which may significantly compromise assessment of the retina, including;
Known hypersensitivity to fluorescein.
Previous retinal or ocular surgery, 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.
Sensitivity to the application of a contact lens.
Any history of prior laser surgery to the retina.
IOP of 26 mm Hg or higher, or if there is some reason to believe that the participant may have glaucoma, (e.g., history of the diagnosis of glaucoma, 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression to advanced age related macular degeneration (AMD) in the treated eye as assessed by clinical ocular examination, colour fundus photography, Ocular Coherence Tomography, and Fluorescein Angiography as required.[36 months post initial laser treatment]

Secondary Outcome Measures

Name	Time	Method
Progression to advanced AMD non-treated eye as assessed by clinical ocular examination, colour fundus photography, Ocular Coherence Tomography, and Fluorescein Angiography as required.[36 months post initial sham laser procedure]