Low dose aspirin and age-related macular degeneration: randomized controlled trial

In people 70 years or older, does low dose of aspirin, compared to placebo, influence the incidence and/or progression of age-related macular degeneration (AMD)?

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000755730

Acronym

ASPREE-AMD

Enrollment

6000

Registered

2013-07-05

Start date

2013-06-28

Completion date

2014-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Age-related macular degeneration (AMD) is a major cause of visual impairment in advanced countries, responsible for nearly half of all legal blindness in Australia. Due to increased life expectancy, the number of people with this progressive late onset disease will double by 2025. Aspirin could prevent or delay the onset of AMD in older persons but its bleeding risk also needs to be considered. This ASPREE-AMD project will determine whether treatment with low dose aspirin reduces incidence or progression of AMD. ASPREE-AMD study is a sub-study of the large-scale randomised controlled trial ASPREE, which is registered with the International Standardised Randomised Controlled Trials Register. Title: Aspirin in Reducing Events in the Elderly (ASPREE). Number: ISRCTN83772183.

Interventions

Acetylsalicylic acid (ASA) 100 mg once daily: enteric-coated un-scored white oral tablets versus placebo. Duration of administration: 5 years. Compliance is monitored annually by pill count. Inclusion compliance must be more than 80 percent, assessed over a 4 week period of daily pill taking prior to randomisation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion criteria for the main ASPREE study will apply to this sub-study. Eligible participants in ASPREE-AMD should be consecutive participants who enter the ASPREE study to maintain balance in treatment groups, according to the block randomisation procedures for the main study. ASPREE Inclusion Criteria: 1. Men and women 2. Any person aged 70 years or older 3. Willing and able to provide informed consent, and willing to accept the study requirements

Exclusion criteria

In addition to the ASPREE exclusion criteria, the exclusion criteria for ASPREE-AMD study include Geographic atrophy or Choroidal neovascular AMD in both eyes, or if baseline images are unavailable/non-existent. ASPREE Exclusion Criteria: 1. A history of a diagnosed cardiovascular event 2. A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease 3. A current or recurrent condition with a high risk of major bleeding, e.g.: cerebral aneurysm 4. Anemia 5. Absolute contraindication or allergy to aspirin 6. Current participation in a clinical trial 7. Current continuous use of aspirin or other anti-platelet drug or anticoagulant for secondary prevention. People with previous use of aspirin for primary prevention may enter the trial, provided they agree to cease existing use of aspirin and understand that they may be subsequently randomly allocated to low dose aspirin or placebo. 8. A systolic blood pressure >/=180 mmHg and / or a diastolic blood pressure >/=105 mmHg 9. A history of dementia 10. Severe difficulty or an inability to perform any one of the 6 Katz Basic Activities of Daily Living (ADL) 11. Non-compliance to taking pill

Outcome results