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P. G. Ralston, Jr., D. Sloan, D. Waters-Honcu, S. Saigal, G. Torkildsen; A Pilot, Open-Label Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Nonexudative Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2010;51(13):913.
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To determine the safety profile of repeated doses of topical MC-1101 in normal and early non-exudative (dry) age-related macular degeneration (AMD) subjects. The effect of MC-1101 on subjects’ choroidal blood flow (ChBF) was also investigated.
In this study, 31 subjects (11 AMD patients and 20 normals) aged 50 to 89 were treated contralaterally with MC-1101 and placebo and dosed a total of 7 times over 3 days. A Nautilus 1.0 VersiDoserTM (Mystic PharmaceuticalsTM) was used to instill 30 microliters of study medication per dose. Safety assessments included vital signs, visual acuity, intraocular pressure, anterior/posterior segment slit-lamp examinations, and AE monitoring. Measurements of ChBF were taken at baseline and at multiple post-drug instillation time points using a compact, confocal laser Doppler flowmeter (Sion, Switzerland).
MC-1101 was found to be safe and well tolerated; no significant safety-related issues were reported. Mild and transitory ocular hyperemia was the most common treatment-related adverse event, which occurred in 21 (68%) MC-1101-treated eyes and 1 (3%) vehicle-treated eye; however, this was expected given MC-1101’s mechanism of action. Results for ChBF found increased blood volume and velocity values in MC-1101-treated eyes 2 hours after dosing, which returned to baseline 2 hours later. In the AMD group, modest increases in blood flow were found 30, 60 and 120 minutes post-dosing at Visit 1. Larger data variation found in AMD subjects suggests that choroidal blood parameters may be more volatile in this group and/or that substantial technical difficulties make accurate choroidal blood flow measurement more difficult in this population.
Repeated dosing with MC-1101 was well-tolerated in both normal and AMD subjects. MC-1101 appears to play a role in the modulation of ChBF following topical administration. Since these results indicate that treatment with MC-1101 may affect choroidal physiology, potential benefits to subjects with dry AMD should be further explored.
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