Age-Related Maculopathy Statin Study

Phase 3

Completed

• Conditions: Age-related macular degeneration; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12605000320651
• 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: 2005-09-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

(1) The ability to assess the macula in at least one eye, (2) VA better than or equal to 6/18 in the study eye(s). (3) High risk drusen in both eyes: one or more large soft druse (125 microns), or >10 intermediate drusen (62.5 microns) ORLate AMD (CNV, GA) in one eye and any drusen or pigment change in the study eye.Note: the study eye is allowed to have non-central GA and/or non-neovascular PED (4) cholesterol level within the normal limits according to the person's medical history (5) not currently on any cholesterol-lowering medication.

Exclusion Criteria

(1) Medical and ophthalmic conditions which potentially affects visual function, including visually significant cataract (as defined by WILMER's grading method-that is nuclear opacity score of 2.00 or greater, cortical opacity score of greater than 3, any posterior subcapsular cataract), history of diabetes and glaucoma(2) Use of medications which may affect visual function, such as plaquenil, chloroquine, major tranquilizers.(3) cholesterol levels outside the normal limits given person's medical history.(a)Existing coronary heart disease:-- cholesterol > 4 mmol/L(b) Diabetics, people with hypertension, peripheral vascular disease, family history of hypercholesterolaemia or coronary heart disease:-- cholesterol > 6.5mmol/L or cholesterol > 5.5 if HDL <1.0mmol/L(c) people with HDL <1.0mmol/L:--cholesterol >6.5mmol/L(d) men aged 35 to 75 years or postmenopausal women up to 75 years:-- cholesterol >7.5 or triglycerides > 4.0mmol/L(e) people with none of the above:--cholesterol >9.0 or triglycerides >8.0mmol/L(4)Statins is clinically contraindicated:(a) Allergy(b) ALT > 2 times the upper limit of normal(c) Previous severe adverse reactions to statin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of high risk early AMD to late AMD.[Evaluation of AMD status every 6 months.]

Secondary Outcome Measures

Name	Time	Method
Dynamics of Visual Functions: Colour sensitivity, Flicker sensitivity, Bleach recovery, Kinetics of Dark adaptation.[Evaluation of visual functions every 6 months.]