Choroidal NeovascularizationPhase 2NCT00426998
Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD
A Phase 2 study testing Verteporfin and Bevacizumab in people with Choroidal Neovascularization and Macular Degeneration, run by Retinal Consultants Medical Group at 1 site in United States.
Trial summary
The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Choroidal Neovascularization, Macular Degeneration
- What is being tested?
- Verteporfin and Bevacizumab
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are men or women of age 55 or older
- Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA
- patients have not received previous treatment for subfoveal CNV due to AMD.
- Patients have a visual acuity between 20/40 and 20/320-
Who cannot join
- Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
- Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
- Patients who use medications that may induce photosensitivity.
- Patients who have undergone YAG capsulotomy within the last month.
- Subjects currently involved in any experimental procedure within the last 12 weeks.
- Female patients who are pregnant, fecund or breast-feeding.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95819
About this study
Official title: A 24 Month Randomized, Double-Masked, Single Center, Phase II Study Comparing Photodynamic Therapy With Verteporfin (Visudyne)Plus Two Different Timing Regimens of Intravitreal Bevacizumab (Avastin) Given 1 Week Prior to or 1 Week Following Photodynamic Therapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.
The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
- Conditions
- Choroidal Neovascularization, Macular Degeneration
- Being tested
- Verteporfin, Bevacizumab
- Keywords
- Choroidal neovascularization due to age-related macular degeneration
- 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.
VerteporfinDrug
BevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients losing 3 or more lines of visual acuity
percentage of patients gaining 3 or more lines of visual acuity
mean change from baseline in visual acuity
OCT evidence of active CNV leakage
fluorescein angiographic evidence of active CNV leakage
number of retreatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startApr 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Retinal Consultants Medical Group
- Sponsor type
- University, hospital or other
- Investigators
- Joel A Pearlman, M.D., Ph. D., Principal investigator, Retinal Consultants Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426998
- Sponsor's protocol ID
- ComB-V001
- Status last verified
- Jan 2007
- First submitted
- 24 Jan 2007
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Month Randomized, Double-Masked, Single Center, Phase II Study Comparing Photodynamic Therapy With Verteporfin (Visudyne)Plus Two Different Timing Regimens of Intravitreal Bevacizumab (Avastin) Given 1 Week Prior to or 1 Week Following Photodynamic Therapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT00426998
- Acronym / sponsor ID
- ComB-V001
- Conditions
- Choroidal Neovascularization, Macular Degeneration
- Keywords
- Choroidal neovascularization due to age-related macular degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Retinal Consultants Medical GroupUniversity, hospital or other
- Study start
- Apr 2006
- First posted
- 26 Jan 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 purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are men or women of age 55 or older
- Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA
- patients have not received previous treatment for subfoveal CNV due to AMD.
- Patients have a visual acuity between 20/40 and 20/320-
Key exclusion criteria (7 listed)
- Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
- Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
- Patients who use medications that may induce photosensitivity.
- Patients who have undergone YAG capsulotomy within the last month.
- Subjects currently involved in any experimental procedure within the last 12 weeks.
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 | Drug | – |
| Bevacizumab | Drug | – |
Primary outcome
percentage of patients losing 3 or more lines of visual acuity
percentage of patients gaining 3 or more lines of visual acuity
mean change from baseline in visual acuity
OCT evidence of active CNV leakage
fluorescein angiographic evidence of active CNV leakage
number of retreatments
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 26 Jan 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.
Joel A Pearlman, M.D., Ph. D. principal investigator
Retinal Consultants Medical Group, Inc.
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 Verteporfin and Bevacizumab in people with Choroidal Neovascularization and Macular Degeneration, run by Retinal Consultants Medical Group at 1 site in United States.
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 4 inclusion and 7 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 26 Jan 2007. 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 United States. 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 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?
percentage of patients losing 3 or more lines of visual acuity. The study lists 6 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 26 Jan 2007.