A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy

Withdrawn before enrolling · Phase 1

Conditions studied: Geographic Atrophy

In brief

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).

Key facts

Study ID

NCT01093170

Run by

Mark Kleinman

People needed

0

Starts

2011-03-01

Expected to finish

2012-09-01

Last updated by the study team

2018-01-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females of all races and ethnicities between the ages of 50-99
• Female subjects must be 1-year postmenopausal or surgically sterilized and must have negative serum pregnancy test
• Subjects must have GA from AMD in one or both eyes:
• The study eye will be the eye that meets all inclusion/exclusion criteria
• If both eyes meet criteria, then the eye with the smaller GA lesion will be studied
• If the GA lesions are equal in size, then the eye with the best-corrected visual acuity (BCVA) will chosen as the study eye
• If both eyes have the same lesion size and same BCVA, the right eye will be chosen
• Subjects must have the following GA criteria for inclusion:
• GA lesions with an area > 2.5mm2 and ≤ 20mm2 as determine by fluorescein angiography and fundus autofluorescence
• A clear view to the fundus must be present in order to easily examine the study eye at baseline
• BCVA In the study eye between 20/20 and 20/100 as measured on Snellen chart or 85-50 letters by ETDRS
• Willing and able to provide signed informed consent prior to any study participation

You may not qualify if…

• GA due to a disease other than AMD
• Pregnancy or lactation
• Treatment of any systemic infection
• Autofluorescence pattern marked at none, focal or patchy
• Ocular surgery in the study eye in the previous 6 months.
• Presence or history of choroidal neovascularization (wet AMD) in the study eye
• Any inflammatory (autoimmune, uveitis) or neovascular (diabetic retinopathy) disease of the retina
• Any history of glaucoma or disc cupping in the study eye
• Any history of severe dry eye disease
• High myopia > - 8D or high hyperopia > +8D in the study eye
• Presence of life-threatening disease
• Abnormal basal metabolic panel or liver function tests
• Current alcohol or other substance abuse
• Unwilling or unable to provide signed informed consent for any study procedures

Where it is running

• University of Kentucky / Dept of Ophthalmology — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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