Macular DegenerationPhase 1NCT00102115
Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease
A Phase 1 study testing Talaporfin Sodium (LS11) Photodynamic Therapy (PDT) in people with Macular Degeneration and Choroidal Neovascularization, run by Light Sciences LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jan 2006
- 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
- Age 50 or older
- Subject is able to sign informed consent
- Ability to complete 6 month trial
- Present with advanced AMD and persistently leaking CNV
- Adequate hematologic, renal and liver function
- Negative pregnancy test
- Subject is able to safely undertake all protocol directed instructions
- Visual acuity of 20/200 (logMAR 1.0)(6/60) or worse
Who cannot join
- Concomitant eye disease in eye to be treated
- Prior ocular radionuclide treatments
- Known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish
- History of investigational drug or therapy including biologics within 30 days prior to the study drug dosing
- Women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions
- History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum
Show all 17Show fewer
- History of clinically significant cardiovascular abnormalities, including myocardial infarction in the past 6 months, uncontrolled arrhythmias, uncontrolled congestive heart failure
- Concomitant use of other drugs known to produce skin photosensitivity, e.g. tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics and griseofulvin, St. John's Wort
- Subjects with high or pathological myopia with an axial length > 26mm or a refractive error of >/= -8.00D
- Subjects with glaucoma and vision loss in either eye
- Subject with a history of other choroidal leakage, e.g. histoplasmosis
- Subjects with significant media opacity
- Subjects diagnosed with diabetic retinopathy
- Subjects who have had eye surgery within the past 3 months
- Subjects who have received PDT treatment for AMD in the treatment eye
- Any disease or condition that the sponsor or the investigator believes will impact the subject's ability to adhere to the study schedule
- Subjects participating in any concurrent trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease
The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).
Read the detailed description
This Phase 1 study is a safety and tolerability investigation of LS11 photodynamic therapy in subjects with persistent leaking neovascular membranes in patients with AMD who have a visual acuity of 20/200 or less. This is a sequential group dose escalation trial with the cohorts defined by increasing the light dose. Within each light-dose cohort, three (3) subjects will be treated at a drug dose of 0.2 mg/kg or 0.5 mg/kg.
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Being tested
- Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)
- Keywords
- Macular disease, Wet AMD, AMD, Age-Related Macular Disease, PDT, Photodynamic Therapy
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talaporfin Sodium (LS11) Photodynamic Therapy (PDT)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
Secondary outcomes (1)
Changes in visual performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2005 (estimated)
- Study startDec 2004
- Study completionJan 2006
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants
Sponsor and investigators
- Lead sponsor
- Light Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Krasner, PhD, Study director, Light Sciences LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102115
- Sponsor's protocol ID
- LSCOR-001
- Status last verified
- Dec 2005
- First submitted
- 21 Jan 2005
- Last updated
- 12 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose Ranging Study to Evaluate Safety and Tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in Subjects With Advanced Age-Related Macular Disease
- ClinicalTrials.gov ID
- NCT00102115
- Acronym / sponsor ID
- LSCOR-001
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Keywords
- Macular disease, Wet AMD, AMD, Age-Related Macular Disease, PDT, Photodynamic Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 27 participants
- Lead sponsor
- Light Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Jan 2006
- First posted
- 24 Jan 2005 (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 safety and tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).
Detailed description
This Phase 1 study is a safety and tolerability investigation of LS11 photodynamic therapy in subjects with persistent leaking neovascular membranes in patients with AMD who have a visual acuity of 20/200 or less. This is a sequential group dose escalation trial with the cohorts defined by increasing the light dose. Within each light-dose cohort, three (3) subjects will be treated at a drug dose of 0.2 mg/kg or 0.5 mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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 (8 listed)
- Age 50 or older
- Subject is able to sign informed consent
- Ability to complete 6 month trial
- Present with advanced AMD and persistently leaking CNV
- Adequate hematologic, renal and liver function
Key exclusion criteria (17 listed)
- Concomitant eye disease in eye to be treated
- Prior ocular radionuclide treatments
- Known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish
- History of investigational drug or therapy including biologics within 30 days prior to the study drug dosing
- Women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions
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 |
|---|---|---|
| Talaporfin Sodium (LS11) Photodynamic Therapy (PDT) | Drug | – |
Primary outcome
Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD
1 secondary outcome
Changes in visual performance
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
- Study sponsorLink provided by the sponsor.
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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.
Gary Krasner, PhD study director
Light Sciences LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talaporfin Sodium (LS11) Photodynamic Therapy (PDT) in people with Macular Degeneration and Choroidal Neovascularization, run by Light Sciences LLC at 1 site 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 17 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: stopped early, as of the sponsor's last update on 12 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 1 site 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 was stopped early. Results are not available in the source record.
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?
Cessation of leakage from choroidal neovascularization (CNV) of subjects with late stage AMD. 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 12 Mar 2010.