NCT01790802

Brief Summary

The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the progression to advanced age-related macular degeneration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

April 15, 2025

Status Verified

July 1, 2018

Enrollment Period

6.5 years

First QC Date

February 12, 2013

Last Update Submit

April 11, 2025

Conditions

Age-related Macular Degeneration

Keywords

laser treatment, high risk, early AMD

Outcome Measures

Primary Outcomes (1)

  • progression to advanced Age-related Macular Degeneration (AMD) in the treated eye

    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

    36 months

Secondary Outcomes (1)

  • progression to advanced AMD in the untreated eye

    36 months

Other Outcomes (2)

  • reversal of early clinical indicators of AMD

    36 months

  • Improvements in visual acuity

    36 months

Study Arms (2)

Active laser

EXPERIMENTAL

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

Sham laser procedure

SHAM COMPARATOR

The maximum illumination button on hte 2RT laser will be briefly pressed by the operating physician at each of the 12 locations where and when the laser would normally be applied. The laser remains in standby mode preventing accidental laser firing.

Device: 2RT nanosecond laser

Interventions

2RT nanosecond laserDEVICE

active laser therapy

Active laserSham laser procedure

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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, optical coherence tomography (OCT) and fundus autofluorescence (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.

You may not qualify if:

  • Any evidence of definite geographic atrophy within the macula (a circle with a radius of 3000 microns centred on the fovea).
  • 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;
  • 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 (Plaquenil), 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

Related Publications (2)

  • Goh KL, Wintergerst MWM, Abbott CJ, Hadoux X, Jannaud M, Kumar H, Hodgson LAB, Guzman G, Janzen S, van Wijngaarden P, Finger RP, Guymer RH, Wu Z. HYPERREFLECTIVE FOCI NOT SEEN AS HYPERPIGMENTARY ABNORMALITIES ON COLOR FUNDUS PHOTOGRAPHS IN AGE-RELATED MACULAR DEGENERATION. Retina. 2024 Feb 1;44(2):214-221. doi: 10.1097/IAE.0000000000003958.

    PMID: 37831941DERIVED

  • Wu Z, Luu CD, Hodgson LAB, Caruso E, Chen FK, Chakravarthy U, Arnold JJ, Heriot WJ, Runciman J, Guymer RH; LEAD Study Group. USING MICROPERIMETRY AND LOW-LUMINANCE VISUAL ACUITY TO DETECT THE ONSET OF LATE AGE-RELATED MACULAR DEGENERATION: A LEAD Study Report. Retina. 2021 May 1;41(5):1094-1101. doi: 10.1097/IAE.0000000000002982.

    PMID: 33009222DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Robyn H Guymer, PhD, FRANZCO

    Deputy Director CERA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 13, 2013

Study Start

November 1, 2011

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

April 15, 2025

Record last verified: 2018-07

Locations

AU(1)