Subthreshold Laser Treatment in Intermediate Age-related Macular Degeneration With Nascent Geographic Atrophy Study

Last updated: April 11, 2025
Sponsor: Center for Eye Research Australia
Overall Status: Terminated

Phase

N/A

Condition

Aging

Macular Degeneration

Myopic Macular Degeneration

Treatment

2RT subthreshold nanosecond laser

Clinical Study ID

NCT05200624
LIANA
  • Ages > 50
  • All Genders

Study Summary

This study is a prospective, single centre, randomized, sham-controlled, double-masked, clinical trial which aims to investigate the effect of subthreshold nanosecond laser on disease progression in eyes with intermediate age-related macular degeneration (AMD) and nascent geographic atrophy by functional and anatomical outcomes.

The study population will be individuals with high-risk intermediate age-related macular degeneration who meet all eligibility criteria. 60 subjects total (30 randomized to receive subthreshold nanosecond laser (SNL) treatment and 30 to receive sham treatment as per the 1:1 randomization).

The study has a 12-month study period with four scheduled visits: screening, randomisation (first treatment), 6-month follow up visit (with second treatment where eligible), 12-month follow-up.

The primary outcome is the proportion of laser-treated study eyes that develop late AMD compared to sham-treated study eyes over 12 months. The key secondary outcome is the change in retinal function of laser-treated study eyes compared to sham-treated study eyes over 12 months. Safety will be the proportion of laser-treated eyes that lose 10+ letters of vision (measured on a standard vision chart) compared to sham-treated eyes over 12 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 50 years or older at time of consent

  2. Best corrected visual acuity (BCVA) of 59 letters (Snellen equivalent of 6/19) orbetter in both eyes

  3. Bilateral large (>125µm) drusen as seen on colour fundus photographs (CFP) asassessed within a circle with radius of 3000µm centred on the fovea

  4. Between 1 to 5 (inclusive) discrete area/s of nascent geographic atrophy (nGA) asseen on SD-OCT B-scan/s within a 20°x20° volume scan centred on the fovea in thestudy eye NOTE: TThe non-study eye does not need to have nGA but can have: anynumber of nGA, iRORA or cRORA lesions (on OCT) but not GA (on CFP or FAF)

  5. Ability, willingness and sufficient cognitive awareness to consent to the trial,received randomized SNL treatment or sham procedure, and complete all visits as perthe study schedule

Exclusion

Exclusion Criteria:

  1. STUDY EYE: A cluster of definitely present reticular pseudodrusen (RPD) of >1 discarea (DA) (i.e., an area approximately 2.54mm2 in size) as seen on near infrared (NIR) imaging, or fundus autofluorescence (FAF) within a 20˚x20˚ field centred onthe fovea

  2. STUDY EYE: A subfoveal pigment epithelial detachment (PED)/drusenoid detachment >1000µm in diameter (measured on the central B-scan) with hyperreflective foci (HRF)and increased choroidal transmission or any PED >2000µm measured at the centralfoveal B-scan

  3. Any evidence of definite geographic atrophy (GA) in either eye

  4. Any evidence of active, regressed or treated macular neovascularization (MNV), ineither eye, or active peripapillary CNV in the study eye (determined on multi-modalimaging and a fundus fluorescein angiogram is only required if in the investigator'smedical judgement) NB: Subretinal fluid (SRF) <100µm or SRF associated with asubfoveal pseudovitelliform lesion permitted (i.e. slither/draping/ vitelliform withno evidence of new vessels on OCT-A) is not considered MNV and can be enrolled.

  5. Any other investigational treatment for AMD, excluding dietary supplements, receivedin the past 12 months or thought, in the opinion of the investigator, likely tochronically change the course of the subject's retinal disease

  6. Current participation in any other investigational ophthalmological clinical trial

  7. Any ocular disease in the study eye, other than AMD, which in the opinion of theinvestigator may significantly compromise assessment of the retina, or which wouldcompromise the ability to assess any effect following SNL treatment including, butnot limited to:

  8. Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/orsmall retinal hemorrhages, without retinal thickening on OCT)

  9. Macular pathology or pigmentary abnormalities atypical of AMD, including butnot limited to: pattern dystrophy, myopic maculopathy, angioid streaks, resumedocular histoplasmosis syndrome, central serous choroidopathy,visually-significant epiretinal membranes, macular hole or pseudohole

  10. Optic nerve pathology, including optic atrophy, history of optic neuropathy

  11. Myopic crescent wider than 50% of the longest diameter of the optic disc, orcloser than 1500 µm to the fovea

  12. Retinal vascular diseases including branch or central vein or artery occlusion

  13. Choroidal nevus within 2 disc diameters (DD) of the fovea associated withdepigmentation or overlying drusen, if these drusen are used to determineeligibility

  14. Active uveitis or ocular inflammation

  15. History or presence of uncontrolled glaucoma

  16. Intraocular pressure which would preclude safe dilation of the pupil to allowadequate assessment and application of SNL treatment

  17. History of prior laser surgery to the retina including subthreshold laser (focalretinopexy for a peripheral break and/or focal retinal tears performed more than 90days prior to the entry into the study is permitted)

  18. Significant cataract or other ocular media which, in the opinion of theinvestigator, significantly limits the visual acuity or view of the retina

  19. Previous retinal or ocular surgery, the effects of which may now or in the futurecomplicate assessment of the progression of AMD. (Cataract surgery is allowed aslong as it was performed over 90 days prior to entry into the study)

  20. Known hypersensitivity to fluorescein

  21. Sensitivity to application of a contact lens

  22. Corneal pathology precluding visualization of fundus or increasing the risk of usinga contact lens, such as corneal dystrophy, recurrent corneal erosion syndrome orsensitivity to the application of a contact lens.

  23. Use of any systemic or ocular medication known to be toxic to the retina, excludingtamoxifen unless there is evidence of toxicity.

  24. Pregnant or lactating women

  25. Subject who is considered ineligible for this study in the investigator's medicaljudgement

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: 2RT subthreshold nanosecond laser
Phase:
Study Start date:
December 13, 2021
Estimated Completion Date:
April 07, 2025

Connect with a study center

  • Marsden Eye Specialists

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Adelaide Eye & Retina Centre

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Centre for Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Retinology Institute

    Melbourne, Victoria 3167
    Australia

    Site Not Available

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