Macular DegenerationPhase 1NCT00536016
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
A Phase 1 study testing JSM6427 in people with Macular Degeneration, run by Jerini Ophthalmic at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- JSM6427
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2007to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Retinal thickness ≥ 250 μm by OCT.
- Normal screening ERG
- Normal ECG
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Vitreoretinal Consultants
Houston, Texas, 77030
Valley Retina Institute
McAllen, Texas, 78503
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73120
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
William Beaumont Research Institute
Royal Oak, Michigan, 40873
Palmetto Retina Center
West Columbia, South Carolina, 29169
About this study
Official title: 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.
Read the 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.
- Conditions
- Macular Degeneration
- Being tested
- JSM6427
- Keywords
- AMD, Neovascular Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSM6427Drug
Weekly intravitreal injections for up to 4 weeks, first dose strength is one dose below the MTD. Dose strength concentrations: 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml 04 15 mg/ml.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability to determine the MTD
Measured: 2 weeks after each dose
Secondary outcomes (1)
To evaluate the systemic pharmacokinetics of JSM6427 following single and repeat doses by intravitreal injection and to assess exploratory efficacy potential of JSM6427
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerini Ophthalmic
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anthony Adamis, MD, Study chair, Jerini Ophthalmic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536016
- Sponsor's protocol ID
- JO642701
- Status last verified
- Sep 2010
- First submitted
- 25 Sep 2007
- Last updated
- 21 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00536016
- Acronym / sponsor ID
- JO642701
- Conditions
- Macular Degeneration
- Keywords
- AMD, Neovascular Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jerini OphthalmicIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JSM6427Weekly intravitreal injections for up to 4 weeks, first dose strength is one dose below the MTD. Dose strength concentrations: 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml 04 15 mg/ml. | Drug | – |
Primary outcome
Safety and Tolerability to determine the MTD
Time frame: 2 weeks after each dose
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Adamis, MD study chair
Jerini Ophthalmic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JSM6427 in people with Macular Degeneration, run by Jerini Ophthalmic at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability to determine the MTD (time frame: 2 weeks after each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2010.