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

Geographic Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01093170
• Other study ID #: 144101a
• Status: Withdrawn
• Phase: Phase 1
• First received: March 22, 2010
• Last updated: January 15, 2018
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Drug:
• RNA-144101
Intravitreous administration of RNA-144101

Locations

Country	Name	City	State
United States	University of Kentucky / Dept of Ophthalmology	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Mark Kleinman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of RNA-144101 as measured by vision testing, ophthalmic and physical exams, vital signs, clinical laboratory testing and AEs.		Through study completion or discontinuation
Secondary	Pharmacokinetic studies measuring drug concentrations in serum over study period.		Through study completion or discontinuation
Secondary	Measurement of total aggregate area of GA lesions (as determined by color fundus photography and autofluorescence imaging)		Through duration of study or discontinuation