Age-related macular degeneration (AMD) Light trial

Phase 1

Completed

• Conditions: Age-related Macular Degeneration; Eye Diseases

• Registration Number: ISRCTN82148651
• Lead Sponsor: Cardiff University (UK)

Brief Summary

1. 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24965385 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30208421 (added 29/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-28
• Study Completion: 2016-06-30
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All participants will be aged between 55 and 88 years of age, may be male or female, and will have a corrected ETDRS visual acuity in the test eye of 40 letters (logMAR 0.3, Snellen 6/12) or better.

Additional inclusion criteria for participants in the trial:
1. A diagnosis of neovascular AMD in one eye only. Participants will have completed within the past month their initial 3 months of Lucentis ® loading injections, and will be entering a 'treatment as required' regime, based around a 4 weekly schedule of check-ups. Fellow eye will be classified as early AMD, characterised by the presence of soft drusen and/or focal pigmentary changes, in the absence of signs of advanced AMD e.g. retinal oedema, exudates, haemorrhage, geographic atrophy.
2. Participants will need to be willing to adhere to the allocated treatment for the duration of the trial.

Additional inclusion criteria for participants in the cross-sectional study:
Normal retinal appearance (controls) or grade 1 AMD (according to the AREDS simplified scale).

Exclusion Criteria

Any potential participant will be excluded if they have:

1. Ocular pathology other than macular disease, including: non-AMD related fundus changes, narrow anterior angles (=grade 1 van Herrick), amblyopia, significant cataract (LOCS III graded, above grade 2 on any criterion), central corneal/media opacity, any posterior eye condition, glaucoma, history of prodromal symptoms of closed angle glaucoma.
2. Significant systemic disease known to affect visual function (e.g. diabetes, Parkinson?s disease, Alzheimer?s disease).
3. History of medication known to affect visual function (e.g. chloroquine, tamoxifen).
4. An insufficient level of English language comprehension to be able to carry out the questionnaires and monthly interviews with study personnel.
5. A history of falls, or a high risk of falling.

Additional exclusion criteria for participants in the trial:
1. A diagnosis of advanced AMD in both eyes.
2. Significant systemic disease that would compromise participation in a 1 year study (e.g. motor neurone disease).
3. Cognitive impairment as determined using an abridged Mini Mental State Examination (Margrain et al. 2012)
4. Oxygen mask worn at night.

Additional exclusion criteria for participants in the cross-sectional study:
Age-related macular degeneration beyond grade 1 on the AREDS simplified scale.

Study & Design

• Study Type: Interventional
• Study Design: Not specified