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This study has been withdrawn prior to enrollment.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:
University of Kentucky
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01093170
First received: March 22, 2010
Last updated: September 17, 2012
Last verified: September 2012
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
Drug Information available for:
Ribonucleic acid
U.S. FDA Resources
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 May 16, 2013