Choroidal NeovascularizationPhase 1/2PBSNCT00570193
Photodynamic and Pharmacologic Treatment of CNV
A Phase 1/2 study testing verteporfin (Visudyne) and ranibizumab (Lucentis) in people with Choroidal Neovascularization and Macular Degeneration, run by Mid-Atlantic Retina Consultations, Inc..
Trial summary
The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroidal Neovascularization, Macular Degeneration
- What is being tested?
- verteporfin (Visudyne) and ranibizumab (Lucentis)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All previously untreated CNV secondary to MD
Who cannot join
None listed.
About this study
Official title: Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)
The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.
- Conditions
- Choroidal Neovascularization, Macular Degeneration
- Being tested
- verteporfin (Visudyne), ranibizumab (Lucentis)
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verteporfin (Visudyne)Drug
Also called Visudyne = verteporfin, Lucentis = ranibizumab
Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1
ranibizumab (Lucentis)Drug
Also called Lucentis = ranibizumab
ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis) Receives: Drug: verteporfin (Visudyne) |
| II | Experimental | Treatment with ranibizumab (Lucentis) Receives: Drug: ranibizumab (Lucentis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual change
Measured: 18 months
Secondary outcomes (1)
Frequency of treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid-Atlantic Retina Consultations, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabil M Jabbour, MD, Principal investigator, Mid-Atlantic Retina Consultations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570193
- Sponsor's protocol ID
- PBS-100-388
- Acronym
- PBS
- Status last verified
- Jul 2012
- First submitted
- 6 Dec 2007
- Last updated
- 10 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)
- ClinicalTrials.gov ID
- NCT00570193
- Acronym / sponsor ID
- PBS / PBS-100-388
- Conditions
- Choroidal Neovascularization, Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mid-Atlantic Retina Consultations, Inc.University, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Dec 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 goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: verteporfin (Visudyne)Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis) |
| II | Experimental | Drug: ranibizumab (Lucentis)Treatment with ranibizumab (Lucentis) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All previously untreated CNV secondary to MD
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| verteporfin (Visudyne)Also: Visudyne = verteporfin, Lucentis = ranibizumabVerteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1 | Drug | I |
| ranibizumab (Lucentis)Also: Lucentis = ranibizumabranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol | Drug | II |
Primary outcome
Visual change
Time frame: 18 months
1 secondary outcome
Frequency of treatment
Time frame: 18 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 10 Jul 2012.
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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.
Nabil M Jabbour, MD principal investigator
Mid-Atlantic Retina Consultations
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing verteporfin (Visudyne) and ranibizumab (Lucentis) in people with Choroidal Neovascularization and Macular Degeneration, run by Mid-Atlantic Retina Consultations, Inc..
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 1 inclusion and 0 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Visual change (time frame: 18 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 10 Jul 2012.