Wet Age-Related Macular DegenerationPhase 1/2ADVANCENCT00138632
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
A Phase 1/2 study testing PTK787 in people with Wet Age-Related Macular Degeneration, run by Novartis at 11 sites in 2 countries.
Trial summary
This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema. In Cohort 1 verteporfin/PDT is the active control. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Wet Age-Related Macular Degeneration
- What is being tested?
- PTK787
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2005to Nov 2007
- Phase
- Phase 1/2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration
- Patients with subfoveal choroidal neovascularization secondary to AMD
Who cannot join
- Eye disease that may result in visual loss during the study
- Uncontrolled high blood pressure, despite chronic stable treatment: systolic ≥ 140 mmHg, Diastolic ≥ 90 mmHg
- Chronic therapy with topical, local or systemic corticosteroids.
- Use of other investigational drugs within 30 days
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States7 sites
Wilmer Eye Institute
Baltimore, Maryland, 21287
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Porter Adventist Hospital, Eye Lab
Denver, Colorado, 80210
Lahey Clinic Medical Center, Eye institute
Peabody, Massachusetts, 01960
Black Hills Regional Eye Institute
Rapid City, South Dakota, 05770
Springfield Clinic, LLP
Springfield, Illinois, 62701
USF Eye Institute
Tampa, Florida, 33612-4742
Australia4 sites
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Parramatta, New South Wales, 2150
Novartis Investigational Site
Sydney, New South Wales, 2000
Novartis Investigative Site
Westmead, New South Wales, 2145
About this study
Official title: A Randomized, Double-Masked, Multicenter, Phase I/II Study of the Safety of PTK787 Administered to Patients With Predominantly Classic , Minimally Classic or Occult With no Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema.
In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the current standard of care for AMD. As a result, ranibizumab is the active control for Cohort 2.
- Conditions
- Wet Age-Related Macular Degeneration
- Being tested
- PTK787, Placebo
- Keywords
- Wet Age-related macular degeneration, PTK787
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK787Drug
Visudyne® + PTK787, 500 mg/day
PTK787Drug
Visudyne® + PTK787 1000 mg/day
PlaceboDrug
Visudyne® + Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PTK787 |
| 2 | Experimental | Not described Receives: Drug: PTK787 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
Measured: up to 12 months
Secondary outcomes (1)
Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3
Measured: from baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionNov 2007
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Customer Information, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138632
- Sponsor's protocol ID
- CPTK787E2201
- Acronym
- ADVANCE
- Status last verified
- Nov 2008
- First submitted
- 29 Aug 2005
- Last updated
- 14 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Multicenter, Phase I/II Study of the Safety of PTK787 Administered to Patients With Predominantly Classic , Minimally Classic or Occult With no Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00138632
- Acronym / sponsor ID
- ADVANCE / CPTK787E2201
- Conditions
- Wet Age-Related Macular Degeneration
- Keywords
- Wet Age-related macular degeneration, PTK787
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Nov 2007 (actual)
- First posted
- 30 Aug 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.
This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema.
In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the current standard of care for AMD. As a result, ranibizumab is the active control for Cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PTK787 |
| 2 | Experimental | Drug: PTK787 |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration
- Patients with subfoveal choroidal neovascularization secondary to AMD
Key exclusion criteria (6 listed)
- Eye disease that may result in visual loss during the study
- Uncontrolled high blood pressure, despite chronic stable treatment: systolic ≥ 140 mmHg, Diastolic ≥ 90 mmHg
- Chronic therapy with topical, local or systemic corticosteroids.
- Use of other investigational drugs within 30 days
- 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 |
|---|---|---|
| PTK787Visudyne® + PTK787, 500 mg/day | Drug | 1 |
| PTK787Visudyne® + PTK787 1000 mg/day | Drug | 2 |
| PlaceboVisudyne® + Placebo | Drug | 3 |
Primary outcome
Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
Time frame: up to 12 months
1 secondary outcome
Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3
Time frame: from baseline up to 3 months
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 14 Nov 2008.
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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 Customer Information study chair
Novartis
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PTK787 in people with Wet Age-Related Macular Degeneration, run by Novartis at 11 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 6 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 14 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months (time frame: up to 12 months). 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 14 Nov 2008.