Age-related Macular DegenerationPhase 3NCT00390026
The Avastin vs Visudyne for Neovascular AMD Study
A Phase 3 study testing Bevacizumab (Avastin) and Verteporfin photodynamic therapy (PDT) in people with Age-related Macular Degeneration, run by St. Erik Eye Hospital at 1 site in Sweden.
Trial summary
The object of the study is to compare the treatment effect of bevacizumab (Avastin), an antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration, the leading cause of vision severe loss in the Western world. 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?
- Bevacizumab (Avastin) and Verteporfin photodynamic therapy (PDT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Nov 2008
- Phase
- Phase 3
- 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
- patients with subfoveal neovascular AMD with either classic/predominantly classic or small occult lesions
- visual acuity >=0.1
Who cannot join
- patients with subfoveal neovascular AMD with minimally classic lesions or large occult lesions
- subfoveal hemorrhage (>1DA) or fibrosis
- patients previously treated for neovascular AMD in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-masked, Controlled Study on Intravitreal Bevacizumab (Avastin) Versus Verteporfin (Visudyne) Photodynamic Therapy (PDT) for Patients With Neovascular Age-related Macular Degeneration (AMD)
The object of the study is to compare the treatment effect of bevacizumab (Avastin), an antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration, the leading cause of vision severe loss in the Western world.
Read the detailed description
Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. Current treatment options have up until now been limited to photodynamic therapy (PDT) where a photosensitizing agent in combination with laser is used to occlude the pathologic vessels. Anti-VEGF agents have recently become available making them a potentially attractive treatment alternative for neovascular AMD. We will compare the effect intravitreally administered bevacizumab with conventional PDT in a prospective, randomized and controlled trial including 100 patients (50 patients receiving either treatment regimen). Non-treated patients will receive either sham-injection or sham-PDT. The primary endpoint of the study is the amount of patients losing less than 15 letters on the ETDRS visual acuity chart. The study will go on for 2 years with an interim report after 1 year.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Bevacizumab (Avastin), Verteporfin photodynamic therapy (PDT)
- Keywords
- Neovascular age-related macular degeneration, Bevacizumab, Photodynamic therapy
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin)Drug
Verteporfin photodynamic therapy (PDT)Drug
| Study group | Role | What they receive |
|---|---|---|
| Avastin | Experimental | Not described Receives: Drug: Bevacizumab (Avastin); Drug: Verteporfin photodynamic therapy (PDT) |
| Visudyne | Active comparator | Not described Receives: Drug: Bevacizumab (Avastin); Drug: Verteporfin photodynamic therapy (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
Measured: 1 year
Secondary outcomes (2)
Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.
Measured: 1 year
Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.
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 posted19 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Lucentis, a treatment superior to PDT, has become available i Sweden.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Erik Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Kvanta, St. Erik Eye Hospital
- Investigators
- Anders Kvanta, MD, PhD, Principal investigator, S:t Erik's Eye HospitalStefan Seregard, MD, PhD, Study director, S:t Eriks Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390026
- Sponsor's protocol ID
- AVA001
- Other IDs
- EU2006-001200-36
- Status last verified
- Jan 2024
- First submitted
- 17 Oct 2006
- Last updated
- 31 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-masked, Controlled Study on Intravitreal Bevacizumab (Avastin) Versus Verteporfin (Visudyne) Photodynamic Therapy (PDT) for Patients With Neovascular Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00390026
- Acronym / sponsor ID
- AVA001
- Conditions
- Age-related Macular Degeneration
- Keywords
- Neovascular age-related macular degeneration, Bevacizumab, Photodynamic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lucentis, a treatment superior to PDT, has become available i Sweden.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Erik Eye HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Oct 2006 (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 object of the study is to compare the treatment effect of bevacizumab (Avastin), an antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration, the leading cause of vision severe loss in the Western world.
Detailed description
Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. Current treatment options have up until now been limited to photodynamic therapy (PDT) where a photosensitizing agent in combination with laser is used to occlude the pathologic vessels. Anti-VEGF agents have recently become available making them a potentially attractive treatment alternative for neovascular AMD. We will compare the effect intravitreally administered bevacizumab with conventional PDT in a prospective, randomized and controlled trial including 100 patients (50 patients receiving either treatment regimen). Non-treated patients will receive either sham-injection or sham-PDT. The primary endpoint of the study is the amount of patients losing less than 15 letters on the ETDRS visual acuity chart. The study will go on for 2 years with an interim report after 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avastin | Experimental | Drug: Bevacizumab (Avastin), Drug: Verteporfin photodynamic therapy (PDT) |
| Visudyne | Active comparator | Drug: Bevacizumab (Avastin), Drug: Verteporfin photodynamic therapy (PDT) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with subfoveal neovascular AMD with either classic/predominantly classic or small occult lesions
- visual acuity >=0.1
Key exclusion criteria (3 listed)
- patients with subfoveal neovascular AMD with minimally classic lesions or large occult lesions
- subfoveal hemorrhage (>1DA) or fibrosis
- patients previously treated for neovascular AMD in the study eye
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 |
|---|---|---|
| Bevacizumab (Avastin) | Drug | Avastin, Visudyne |
| Verteporfin photodynamic therapy (PDT) | Drug | Avastin, Visudyne |
Primary outcome
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
Time frame: 1 year
2 secondary outcomes
Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.
Time frame: 1 year
Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Hospital homepageLink 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.
Anders Kvanta, MD, PhD principal investigator
S:t Erik's Eye Hospital
Stefan Seregard, MD, PhD study director
S:t Eriks Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab (Avastin) and Verteporfin photodynamic therapy (PDT) in people with Age-related Macular Degeneration, run by St. Erik Eye Hospital at 1 site in Sweden.
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 3 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: withdrawn, as of the sponsor's last update on 31 Jan 2024. 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 Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart. (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 31 Jan 2024.