Neovascular Age-related Macular DegenerationPhase 2ARMASTNCT00696592
Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-related Macular Degeneration
A Phase 2 study testing Bevacizumab (Avastin), Verteporfin (Visudyne) in people with Neovascular Age-related Macular Degeneration, run by University of Padova at 1 site in Italy.
Trial summary
This phase II study was designed to evaluate the safety, tolerability, and efficacy of bevacizumab treatment in conjunction with PDT at the low fluence rate compared with bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all types of choroidal neovascularization secondary to AMD. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Bevacizumab (Avastin), Verteporfin (Visudyne)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2007to 31 Jan 2008
- Phase
- Phase 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All lesion subtype of CNV secondary to age-related macular.
- sub-foveal CNV.
- patients who fail to respond to Photodynamic therapy.
- patients who are not eligible for PDT (Greatest linear dimension of the lesion >/= 5400 um, CNV with hemorrhage >/= 50 % of the entire lesion, minimally classic or occult CNV with greatest linear dimension of the lesion >/= 4600 um.).
- Patients affected by Pigment Epithelium Detachment with CNV.
- Patients affected by Retinal Angiomatous Proliferation.
- Willingness and ability to participate and provide written informed consent.
Who cannot join
- Individuals with choroidal neovascularization from causes other than AMD (Myopia, Angioid Streaks).
- Any intraocular surgery within 2 months in the study eye.
- Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.
- Any significant ocular disease that has compromised or could compromise vision in the study eye.
- Prior stroke, myocardial infarction, or end-stage malignancy.
- Active hepatitis or clinically significant liver disease, renal failure.
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- Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
- Patients who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.
- Patients who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Open Label, Phase II Study of Visudyne® Photodynamic Therapy (PDT) Combined With Bevacizumab (Avastin) vs Avastin Alone in Patients With Neovascular Age-related Macular Degeneration (AMD)
This phase II study was designed to evaluate the safety, tolerability, and efficacy of bevacizumab treatment in conjunction with PDT at the low fluence rate compared with bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all types of choroidal neovascularization secondary to AMD.
Hypothesis: bevacizumab in combination with PDT (low and standard fluence rate) will i) delay time to retreatment, ii) reduce the average number of treatments required compared to bevacizumab alone and iii) at low PDT fluence rate will improve long-term safety profile.
- Being tested
- Bevacizumab (Avastin), Verteporfin (Visudyne)
- Keywords
- Age-Related Macular Degeneration, Choroidal Neovascularization, Bevacizumab, 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.
Bevacizumab (Avastin), Verteporfin (Visudyne)Drug
| Study group | Role | What they receive |
|---|---|---|
| BVZ and PDT | Experimental | Not described Receives: Drug: Bevacizumab (Avastin), Verteporfin (Visudyne) |
| BVZ only | Active comparator | Not described Receives: Drug: Bevacizumab (Avastin), Verteporfin (Visudyne) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bevacizumab injections
Measured: One year
The mean change in best-corrected ETDRS visual acuity in the study eye
Measured: Months 6 and 12
Secondary outcomes (4)
Mean change in total CNV area (Disc Areas)
Measured: Months 6 and 12
Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).
Measured: Months 6 and 12
NEI VFQ-25 (vision-related quality of life) score
Measured: One year
Pelli-Robson Contrast Sensitivity Score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study start31 Jan 2007 (estimated)
- Primary completion31 Jan 2008
- Study completion31 Jan 2008
Why it stopped: new data from clinical trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Ophthalmology, Conegliano Hospital, Treviso, Italy
- Responsible party
- Principal investigator, Stefano Piermarocchi, University of Padova
- Investigators
- Stefano Piermarocchi, M.D., Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696592
- Sponsor's protocol ID
- 01-01-ARMAST-2007
- Acronym
- ARMAST
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2008
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open Label, Phase II Study of Visudyne® Photodynamic Therapy (PDT) Combined With Bevacizumab (Avastin) vs Avastin Alone in Patients With Neovascular Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00696592
- Acronym / sponsor ID
- ARMAST / 01-01-ARMAST-2007
- Keywords
- Age-Related Macular Degeneration, Choroidal Neovascularization, Bevacizumab, Photodynamic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: new data from clinical trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Department of Ophthalmology, Conegliano Hospital, Treviso, Italy
- Study start
- 31 Jan 2007 (estimated)
- Primary completion
- 31 Jan 2008 (actual)
- Study completion
- 31 Jan 2008 (actual)
- First posted
- 12 Jun 2008 (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 phase II study was designed to evaluate the safety, tolerability, and efficacy of bevacizumab treatment in conjunction with PDT at the low fluence rate compared with bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all types of choroidal neovascularization secondary to AMD.
Hypothesis: bevacizumab in combination with PDT (low and standard fluence rate) will i) delay time to retreatment, ii) reduce the average number of treatments required compared to bevacizumab alone and iii) at low PDT fluence rate will improve long-term safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BVZ and PDT | Experimental | Drug: Bevacizumab (Avastin), Verteporfin (Visudyne) |
| BVZ only | Active comparator | Drug: Bevacizumab (Avastin), Verteporfin (Visudyne) |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All lesion subtype of CNV secondary to age-related macular.
- sub-foveal CNV.
- patients who fail to respond to Photodynamic therapy.
- patients who are not eligible for PDT (Greatest linear dimension of the lesion >/= 5400 um, CNV with hemorrhage >/= 50 % of the entire lesion, minimally classic or occult CNV with greatest linear dimension of the lesion >/= 4600 um.).
- Patients affected by Pigment Epithelium Detachment with CNV.
Key exclusion criteria (9 listed)
- Individuals with choroidal neovascularization from causes other than AMD (Myopia, Angioid Streaks).
- Any intraocular surgery within 2 months in the study eye.
- Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.
- Any significant ocular disease that has compromised or could compromise vision in the study eye.
- Prior stroke, myocardial infarction, or end-stage malignancy.
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), Verteporfin (Visudyne) | Drug | BVZ and PDT, BVZ only |
Primary outcome
Number of Bevacizumab injections
Time frame: One year
The mean change in best-corrected ETDRS visual acuity in the study eye
Time frame: Months 6 and 12
4 secondary outcomes
Mean change in total CNV area (Disc Areas)
Time frame: Months 6 and 12
Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).
Time frame: Months 6 and 12
NEI VFQ-25 (vision-related quality of life) score
Time frame: One year
Pelli-Robson Contrast Sensitivity Score
Time frame: One 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 24 Apr 2025.
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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.
Stefano Piermarocchi, M.D. principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab (Avastin), Verteporfin (Visudyne) in people with Neovascular Age-related Macular Degeneration, run by University of Padova at 1 site in Italy.
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 7 inclusion and 9 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 24 Apr 2025. 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 Italy. 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 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 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?
Number of Bevacizumab injections (time frame: One year). The study lists 2 primary outcomes in all. 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 24 Apr 2025.