Wet Age-Related Macular DegenerationPhase 1NCT00503022
Safety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration
A Phase 1 study testing ACZ885 in people with Wet Age-Related Macular Degeneration, run by Novartis at 8 sites in 2 countries.
Trial summary
This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885. It also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-Related Macular Degeneration
- What is being tested?
- ACZ885
- How many people
- 20 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2006to not given
- 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
- Adult, Older adult
Who may be able to join
- Male or female ≥ 50 years old, with aged related macular degeneration
- Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
Who cannot join
- Active intraocular inflammation or ocular infection in the study eye
- Eye disease that may result in visual loss during the study
- Chronic therapy with topical, local or systemic corticosteroids.
- Pregnant or nursing (lactating) women.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom7 sites
Study site
Belfast, Northern Ireland
Study site
Bristol
Study site
Liverpool
Study site
London
Study site
Nottingham
Study site
Southampton
Study site
Wolverhampton
About this study
Official title: A Randomized, Double-Masked, Multi-Center Phase I Study of 6 Months Duration to Assess the Safety and Tolerability of Intravenous ACZ885 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885. It also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema.
- Conditions
- Wet Age-Related Macular Degeneration
- Being tested
- ACZ885
- Keywords
- Wet age-related macular degeneration, ACZ885
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZ885Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, electrocardiograms (ECGs) and vital signs over 6 months, following single intravenous infusion of ACZ885.
Secondary outcomes (1)
Changes in central macular edema from Baseline up to Month 6 Changes in best-corrected visual acuity from Baseline up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet 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
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis EH 001 862 778 8300, Study chair, COREC,UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503022
- Sponsor's protocol ID
- CACZ885F2201
- Status last verified
- Dec 2007
- First submitted
- 17 Jul 2007
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Multi-Center Phase I Study of 6 Months Duration to Assess the Safety and Tolerability of Intravenous ACZ885 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00503022
- Acronym / sponsor ID
- CACZ885F2201
- Conditions
- Wet Age-Related Macular Degeneration
- Keywords
- Wet age-related macular degeneration, ACZ885
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- First posted
- 18 Jul 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.
This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885. It also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female ≥ 50 years old, with aged related macular degeneration
- Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
Key exclusion criteria (4 listed)
- Active intraocular inflammation or ocular infection in the study eye
- Eye disease that may result in visual loss during the study
- Chronic therapy with topical, local or systemic corticosteroids.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| ACZ885 | Drug | – |
Primary outcome
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, electrocardiograms (ECGs) and vital signs over 6 months, following single intravenous infusion of ACZ885.
1 secondary outcome
Changes in central macular edema from Baseline up to Month 6 Changes in best-corrected visual acuity from Baseline up to Month 6
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 28 Dec 2007.
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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.
Novartis EH 001 862 778 8300 study chair
COREC,UK
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACZ885 in people with Wet Age-Related Macular Degeneration, run by Novartis at 8 sites in 2 countries.
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 2 inclusion and 4 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Switzerland. 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?
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, electrocardiograms (ECGs) and vital signs over 6 months, following single intravenous infusion of ACZ885.. 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 28 Dec 2007.