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R.H. Guymer, A. Chiu, L. Robman, R.K. O'Loughlin, G. Tikellis, P. Dimitrov, A. Dowrick, C. Nicolas, A.J. Vingrys; Slowing Progression of Age-Related Macular Degeneration With Statins: A Randomised, Controlled Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1807.
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Purpose: Until prevention and more effective treatments are available, intervention to slow the progression of Age-related macular degeneration to the late, visually devastating stage is essential. The primary aim of this study is to determine if psychophysical parameters indicating poor photoreceptor function can be improved with statin treatment (HMG CoA reductase inhibitors) and to correlate this with any slowing of the progression of AMD fundus characteristics. Methods: A power analysis indicates that 200 recruits will be required to detect change in this study. Eligible patients have: (1) at least one high risk AMD fundus characteristic (2) have normo-cholesterolaemia, (3) not be using cholesterol lowering drugs. Eligible participants are randomized to Simvastatin 40mg or placebo for three years. Symptoms of poor photoreceptor function are being documented and psychophysical testing (rod and cone) is being performed on all subjects at baseline and at 6 monthly intervals during the period of the trial. Fundus photographs are being taken and graded using the Wisconsin grading scheme. Results: Since March 2002 165 eligible subjects have been identified from clinics and private rooms on the basis of examination and fundus photos. Exclusions include: 55 subjects (33%) due to current use of cholesterol lowering medications and 30 subjects (18%) on the basis of unrecognized elevated cholesterol levels. Of the remaining subjects 29 have declined participation and 5 did not undergo functional testing. The remainder, 46 subjects have been tested, randomized and started on medication. At baseline 23/46 (50%) report symptoms consistent with RPE dysfunction, 32/46 (70%) showed abnormal rod kinetics and 23/46 (50%) showed delayed cone recovery at baseline. Conclusions: Recruitment to this trial is continuing. To date 50% of recruits have abnormal cone and 70% abnormal rod recovery at baseline which we will continue to monitor for the next 3 years to determine whether statins can improve photoreceptor function which may translate to a slower progression of AMD to sight threatening complications.
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