Dry Age Related Macular DegenerationPhase 1NCT00541333
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
A Phase 1 study testing Copaxone Injection in people with Dry Age Related Macular Degeneration, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age Related Macular Degeneration
- What is being tested?
- Copaxone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2012
- 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
- Dry AMD in one or both eyes
- Age 50 or above of either gender
- Signed informed consent.
Who cannot join
- Known sensitivity to Mannitol or Copaxone.
- Skin disease or active infection of skin.
- Active fever or active treatment for infection.
- History of other uncontrolled systemic active disease.
- Premenopausal females not using reliable birth control.
- Sensitivity to fluorescein or iodine.
- Inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may open a new avenue of preventive treatment for the disease which is the major cause of legal blindness in the industrial world
- Conditions
- Dry Age Related Macular Degeneration
- Being tested
- Copaxone Injection
- Keywords
- Dry Age Related Macular Degeneration, Dry AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copaxone InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Copaxone | Active comparator | Not described Receives: Drug: Copaxone Injection |
| Sham | Sham comparator | Not described Receives: Drug: Copaxone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total drusen area reduction
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 posted10 Oct 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2012
Why it stopped: Reviewing data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard B Rosen, MD, Principal investigator, New York Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541333
- Sponsor's protocol ID
- NYEE100907
- Status last verified
- May 2013
- First submitted
- 9 Oct 2007
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00541333
- Acronym / sponsor ID
- NYEE100907
- Conditions
- Dry Age Related Macular Degeneration
- Keywords
- Dry Age Related Macular Degeneration, Dry AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Reviewing data
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2012 (actual)
- First posted
- 10 Oct 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 the project is to investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may open a new avenue of preventive treatment for the disease which is the major cause of legal blindness in the industrial world
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copaxone | Active comparator | Drug: Copaxone Injection |
| Sham | Sham comparator | Drug: Copaxone Injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dry AMD in one or both eyes
- Age 50 or above of either gender
- Signed informed consent.
Key exclusion criteria (7 listed)
- Known sensitivity to Mannitol or Copaxone.
- Skin disease or active infection of skin.
- Active fever or active treatment for infection.
- History of other uncontrolled systemic active disease.
- Premenopausal females not using reliable birth control.
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 |
|---|---|---|
| Copaxone Injection | Drug | Copaxone, Sham |
Primary outcome
Total drusen area reduction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Richard B Rosen, MD principal investigator
New York Eye and Ear Infirmary
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 Copaxone Injection in people with Dry Age Related Macular Degeneration, run by The New York Eye & Ear Infirmary 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 3 inclusion and 7 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: paused, as of the sponsor's last update on 3 May 2013. 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. Some participants in this study may receive a placebo. 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?
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?
Total drusen area reduction (time frame: 1 year). 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 3 May 2013.