- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536016
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
September 20, 2010 updated by: Jerini Ophthalmic
A Phase 1 Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeated Doses of JSM6427 Following Administration by Intravitreal Injection in Patients With Neovascular AMD
The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye.
Repeated dosages will also be given to determine the highest safe dose.
Study Overview
Detailed Description
In non-clinical models, JSM6427 can lead to the inhibition and regression of choroidal neovascularization, making α5β1 an attractive target for therapeutic strategies directed at pathological angiogenesis.
JSM6427 may also interfere with other key processes in the pathogenesis of AMD, namely inflammation and fibrosis.
Further, non-clinical data show that JSM6427 inhibits scarring and inflammation.
Thus, JSM6427 may target multiple important pathways in the pathogenesis of neovascular AMD.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Beverly Hills, California, United States, 90211
- Retina Vitreous Associates Medical Group
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Ophthalmic Consultants of Boston
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Michigan
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Royal Oak, Michigan, United States, 40873
- William Beaumont Research Institute
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Dean McGee Eye Institute
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South Carolina
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West Columbia, South Carolina, United States, 29169
- Palmetto Retina Center
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Black Hills Regional Eye Institute
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Texas
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Abilene, Texas, United States, 79606
- Retina Research Institute of Texas
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Houston, Texas, United States, 77030
- Vitreoretinal Consultants
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McAllen, Texas, United States, 78503
- Valley Retina Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Best corrected visual acuity in the study eye between 5 and 7 letters inclusive using and ETDRS chart (Snellen equivalent of appx. 20/800 to 20/40.
- Subfoveal choroidal neovascularization (CNV) due to AMD.
- Total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≤ 12 DA, of which at least 25% must be active CNV.
- For patients with occult or non classic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of three or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks.
- Clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening.
- Intraocular pressure of 21 mm Hg or less.
- Retinal thickness ≥ 250 μm by OCT.
- Normal screening ERG
- Normal ECG
Exclusion Criteria:
- PDT within 120 days prior to screening in the study eye.
- Previous therapeutic radiation to the eye.
- Any retinovascular disease or retinal degeneration other than AMD.
- Serous pigment epithelial detachment without the presence of neovascularization.
- Presence of pigment epithelial tears or rips.
- Previous posterior vitrectomy or retinal surgery.
- Any periocular infection in the past 4 weeks.
- Concomitant therapy with anti-VEGF therapies, e.g. Avastin, Lucentis or Macugen, or previous use of these agents within 60 days of screening in the study eye.
- Concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening.
- Cataract surgery in the study eye within three months of screening.
- Intraocular surgery in the study eye within three months of screening.
- Presence of ocular infection in the study eye.
- Presence of severe myopia (-8 diopters or greater) in the study eye.
- Allergy to or prior significant adverse reaction to fluorescein.
- Any major surgical procedure within one month of trial entry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Tolerability to determine the MTD
Time Frame: 2 weeks after each dose
|
2 weeks after each dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the systemic pharmacokinetics of JSM6427 following single and repeat doses by intravitreal injection and to assess exploratory efficacy potential of JSM6427
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Anthony Adamis, MD, Jerini Ophthalmic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 25, 2007
First Submitted That Met QC Criteria
September 26, 2007
First Posted (Estimate)
September 27, 2007
Study Record Updates
Last Update Posted (Estimate)
September 21, 2010
Last Update Submitted That Met QC Criteria
September 20, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JO642701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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