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

This study has been withdrawn prior to enrollment.
(Study was not conducted, no subjects recruited.)
Sponsor:
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01093170
First received: March 22, 2010
Last updated: September 17, 2012
Last verified: September 2012

March 22, 2010
September 17, 2012
March 2011
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01093170 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic studies measuring drug concentrations in serum over study period. [ Time Frame: Through study completion or discontinuation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy
A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Geographic Atrophy
Drug: RNA-144101
Intravitreous administration of RNA-144101
Experimental: RNA-144101
Intervention: Drug: RNA-144101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01093170
144101a
No
Jayakrishna Ambati, M.D., University of Kentucky
University of Kentucky
Not Provided
Principal Investigator: Jayakrishna Ambati, MD University of Kentucky
University of Kentucky
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP