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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014