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Abstract Purpose: Telomere attrition and corresponding cellular senescence of the retinal pigment epithelium (RPE) contribute to the changes of age-related macular degeneration (AMD). Activation of the enzyme telomerase can add telomeric DNA to RPE chromosome ends and has been proposed as a treatment for AMD. We report for the first time the use of a small molecule, oral telomerase activator (TA-65) in a randomized controlled study of subjects with a serious medical condition. This study, focusing on early macular degeneration, provides a model for the use of telomerase activator in age-related disease.
Methods: Thirty-eight patients were randomly assigned to a one-year, double-blinded, placebo-controlled interventional study with arms for oral TA-65 or place-bo. Macular functions via micro-perimetry were the primary measured outcomes. Results: The macular function in the arm receiving TA-65 showed significant improvement relative to the placebo control. The improvement was manifest at six months and was maintained at one year: macular threshold sensitivity, measured as average dB (logarithmic decibel scale of light attenuation) improved 0.97 dB compared to placebo (p=0.02) and percent reduced thresholds lessened 8.2% compared to the placebo arm (p=0.04).
Conclusion: The oral telomerase activator significantly improved the macular function of treatment subjects compared to controls. Although this study was a pilot and a larger study is being planned, it is noteworthy in that it is, to our knowledge, the first randomized placebo controlled study of a safe telomerase activator supplement.Key words: drusen, macular degeneration, micro-perimetry, senescence, telomerase activation, telomere