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This study has been withdrawn prior to enrollment.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
  Purpose

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).


Condition Intervention Phase
Geographic Atrophy
Drug: RNA-144101
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: March 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RNA-144101 Drug: RNA-144101
Intravitreous administration of RNA-144101

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093170

Locations
United States, Kentucky
University of Kentucky / Dept of Ophthalmology
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Jayakrishna Ambati, MD University of Kentucky
  More Information

No publications provided

Responsible Party: Jayakrishna Ambati, M.D., University of Kentucky
ClinicalTrials.gov Identifier: NCT01093170     History of Changes
Other Study ID Numbers: 144101a
Study First Received: March 22, 2010
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014