Age-Related Macular DegenerationPhase 1ASaPNCT00473928
Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD)
A Phase 1 study testing POT-4 in people with Age-Related Macular Degeneration, run by Potentia Pharmaceuticals, Inc. at 6 sites in United States.
Trial summary
The objective of this study is to provide initial safety and tolerability information of intravitreal POT-4 for treatment of patients with AMD Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- POT-4
- Type of treatment
- Injection or infusion
- How many people
- 27 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2007to Feb 2010
- 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
- Understand and sign the IRB-approved informed consent document for the study.
- Age ≥ 50 years.
- In the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm.
- In the study eye, the presence of a choroidal neovascular lesion, either predominantly or minimally classic or occult with no classic in nature, determined by the Digital Angiography Reading Center (DARC) with the CNV defined by its fluorescein angiographic (FA) features.
- The lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself.
- Visual acuity of 20/60 or worse in the study eye as measured on an ETDRS chart.
- Retinal photographs and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained.
- Willingness to comply with the protocol.
Who cannot join
- Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.
- Decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
- Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina.
- Cataract surgery within three months of enrolment.
- Presence of hemorrhage greater than 50% of the CNV lesion.
- Previous PDT treatment in the study eye (eye to be treated) within 30 days prior to enrollment in the study.
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- Previous extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye (eye to be treated) is allowed, if performed at least 30 days prior to enrollment in the study.
- Previous Macugen (pegaptanib) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study.
- Previous Lucentis (ranibizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study.
- Previous Avastin (bevacizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study.
- Previous corticosteroid injection in the study eye (eye to be treated) within 180 days prior to enrollment in the study.
- History of peribulbar corticosteroid injection within 6 months prior to the start of the trial.
- History of oral steroid use at any time during the 30 days prior to randomization.
- Intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization.
- Participation in any other clinical study or are receiving, or have received any experimental systemic treatment for AMD (e.g.: retinoic acid, thalidomide) or any other investigational new drug within 12 weeks prior to the start of study treatment.
- Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, end stage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.
- Advance coronary artery disease or cerebral vascular disease.
- Premenopausal women not using adequate contraception
- Pregnancy or lactation
- Hypersensitivity to Fluorescein
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
United States, California
Beverly Hills, California, 90211
United States, Florida
Gainesville, Florida, 32610
United States, Florida
Miami, Florida, 33136
United States, New Hampshire
Portsmouth, New Hampshire, 03801
United States, Minnesota
Rochester, Minnesota, 55905
United States, Arizona
Tucson, Arizona, 85704
About this study
Official title: Assessment of Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD)
The objective of this study is to provide initial safety and tolerability information of intravitreal POT-4 for treatment of patients with AMD
Read the detailed description
Age-related macular degeneration (AMD) is the leading cause of blindness for individuals over fifty-five years of age that live in the industrialized world. It affects 5-10 million people in the US and as many as 30 million worldwide. There are two forms of the disease, both of which cause a loss of central vision. Approximately eighty-five percent of patients have the less severe dry form that produces gradual but rarely complete vision loss. The remaining fifteen percent have the severe wet, or exudative, form that causes rapid, disabling blindness. Wet AMD is further characterized by choroidal neovascularization (CNV), a growth under the macula of abnormal blood vessels originating from the choroidal capillary bed. Research has linked chronic inflammation to both forms of AMD.
Only recently, unrestrained complement activation was identified in genetic studies to be one of the key mechanisms in the pathogenesis of AMD. It has also been demonstrated that complement activation plays a crucial role in the development of CNV. Therefore, the use of intravitreal complement inhibitors may be beneficial in participants subjects with neovascular AMD.
This prospective, uncontrolled, non-randomized, dose-escalating, pilot Phase I study will provide initial safety and tolerability information on intravitreal complement inhibitor (POT-4) therapy in AMD patients with subfoveal CNV.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- POT-4
- Keywords
- Macular, degeration, Complement
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POT-4Drug
Single intravitreal injection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic assessments of participant safety. - Incidence and severity of ocular adverse events - Incidence and severity of non-ocular adverse events
Measured: Within 30 days after POT-4 administration
Secondary outcomes (1)
Secondary outcomes will investigate the safety and further define the efficacy profile including changes in visual acuity, retinal thickening, and CNV lesion (size and composition).
Measured: For up to a year after POT-4 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Potentia Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jason Slakter, MD, Principal investigator, Potentia Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473928
- Sponsor's protocol ID
- POT-CP1006
- Acronym
- ASaP
- Status last verified
- Mar 2010
- First submitted
- 14 May 2007
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00473928
- Acronym / sponsor ID
- ASaP / POT-CP1006
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Macular, degeration, Complement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Potentia Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 May 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 objective of this study is to provide initial safety and tolerability information of intravitreal POT-4 for treatment of patients with AMD
Detailed description
Age-related macular degeneration (AMD) is the leading cause of blindness for individuals over fifty-five years of age that live in the industrialized world. It affects 5-10 million people in the US and as many as 30 million worldwide. There are two forms of the disease, both of which cause a loss of central vision. Approximately eighty-five percent of patients have the less severe dry form that produces gradual but rarely complete vision loss. The remaining fifteen percent have the severe wet, or exudative, form that causes rapid, disabling blindness. Wet AMD is further characterized by choroidal neovascularization (CNV), a growth under the macula of abnormal blood vessels originating from the choroidal capillary bed. Research has linked chronic inflammation to both forms of AMD.
Only recently, unrestrained complement activation was identified in genetic studies to be one of the key mechanisms in the pathogenesis of AMD. It has also been demonstrated that complement activation plays a crucial role in the development of CNV. Therefore, the use of intravitreal complement inhibitors may be beneficial in participants subjects with neovascular AMD.
This prospective, uncontrolled, non-randomized, dose-escalating, pilot Phase I study will provide initial safety and tolerability information on intravitreal complement inhibitor (POT-4) therapy in AMD patients with subfoveal CNV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understand and sign the IRB-approved informed consent document for the study.
- Age ≥ 50 years.
- In the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm.
- In the study eye, the presence of a choroidal neovascular lesion, either predominantly or minimally classic or occult with no classic in nature, determined by the Digital Angiography Reading Center (DARC) with the CNV defined by its fluorescein angiographic (FA) features.
- The lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself.
Key exclusion criteria (20 listed)
- Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.
- Decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
- Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina.
- Cataract surgery within three months of enrolment.
- Presence of hemorrhage greater than 50% of the CNV lesion.
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 |
|---|---|---|
| POT-4Single intravitreal injection. | Drug | – |
Primary outcome
Local and systemic assessments of participant safety. - Incidence and severity of ocular adverse events - Incidence and severity of non-ocular adverse events
Time frame: Within 30 days after POT-4 administration
1 secondary outcome
Secondary outcomes will investigate the safety and further define the efficacy profile including changes in visual acuity, retinal thickening, and CNV lesion (size and composition).
Time frame: For up to a year after POT-4 administration
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 18 Mar 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.
Jason Slakter, MD principal investigator
Potentia Pharmaceuticals
6 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 POT-4 in people with Age-Related Macular Degeneration, run by Potentia Pharmaceuticals, Inc. at 6 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 8 inclusion and 20 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 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Local and systemic assessments of participant safety. - Incidence and severity of ocular adverse events - Incidence and severity of non-ocular adverse events (time frame: Within 30 days after POT-4 administration). 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 18 Mar 2010.