Clinical Trial: A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy
Brief Summary: This is a non-randomized, open-label, dose-escalating Phase Ia study performed at a single center designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of intravitreous administration of RNA-144101 in patients with geographic atrophy (GA).
Detailed Summary:
Sponsor: University of Kentucky
Current Primary Outcome: Safety and tolerability of RNA-144101 as measured by vision testing, ophthalmic and physical exams, vital signs, clinical laboratory testing and AEs. [ Time Frame: Through study completion or discontinuation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetic studies measuring drug concentrations in serum over study period. [ Time Frame: Through study completion or discontinuation ]
- Measurement of total aggregate area of GA lesions (as determined by color fundus photography and autofluorescence imaging) [ Time Frame: Through duration of study or discontinuation ]
Original Secondary Outcome: Same as current
Information By: University of Kentucky
Dates:
Date Received: March 22, 2010
Date Started: March 2011
Date Completion: October 2011
Last Updated: September 17, 2012
Last Verified: September 2012
