Macular DegenerationPhase 1NCT00403442
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
A Phase 1 study testing Verteporfin Therapy/ Drug: Bevacizumab in people with Macular Degeneration, run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.
Trial summary
The purpose of this study is to explore the combination of PDT with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage >50% of total lesion area). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Verteporfin Therapy/ Drug: Bevacizumab
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to not given
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are men or women of age 50 or older.
- Patients diagnosed with subfoveal CNV due to AMD with lesion size ≤6 DA.
- Patients have not received previous treatment for subfoveal CNV, in the study eye.
- Patients with visual acuities at baseline between 20/40 and 20/320, as evaluated on ETDRS scale.
- Fluorescein Angiography showing any type of subfoveal CNV at baseline with >50% blood component of total lesion area.
Who cannot join
- 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 with history of glaucoma requiring treatment, or are currently on antihypertensive treatment for elevated intraocular pressure.
- Women of childbearing potential must not be pregnant of lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control.
- Patients who have had treatment for CNV in the study eye with photodynamic therapy (PDT), transpupillary thermotherapy (TTT), or other local treatment (e.g. submacular surgery, intravitreal triamcinolone, intra-ocular antiangiogenic agents). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
- Subject's currently who have been involved in any experimental procedure within the last 12 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreous Retina Macula Consultants of New York, P.C.
New York, New York, 10022
About this study
The purpose of this study is to explore the combination of PDT with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage >50% of total lesion area).
To assess the safety of bevacizumab in combination with verteporfin PDT (reduced fluence: 300 mW/cm2) as compared to bevacizumab in combination with verteporfin PDT (standard fluence: 600 mW/cm2) in patients whose neovascular CNV lesions containing >50% blood.
Read the detailed description
This is a phase one study in patients with all CNV lesion subtypes who are naïve to previous treatment. Lesions must have blood as a primary component (i.e., contain more than 50% blood). Patients will receive one of two combination treatments:
- Verteporfin PDT reduced fluence (300 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection
- Verteporfin PDT standard fluence (600 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection A total of 10 patients will be enrolled, 5 per treatment arm.
- Conditions
- Macular Degeneration
- Being tested
- Verteporfin Therapy/ Drug: Bevacizumab
- Keywords
- Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verteporfin Therapy/ Drug: BevacizumabDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety variable is visual acuity and adverse events at Month 12.
Secondary outcomes (6)
Change in percentage of lesion hemorrhage from baseline.
The proportion of patients who lose fewer than 15 letters Less than 3 lines of best corrected visual acuity in the study eye from baseline
The proportion of patients who gain 15 letters or more greater or equal to 3 lines of best-corrected visual acuity in the study eye from baseline
Mean change from baseline in best-corrected visual acuity score. OCT evidence of active CNV leakage which may include persistent retinal edema, subretinal
fluid or pigment epithelial detachment. FA evidence of active CNV leakage which may include subretinal fluid or hemorrhage.
Number of retreatments, bevacizumab and verteporfin PDT, at either fluence rate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New York
- Sponsor type
- University, hospital or other
- Collaborators
- QLT Inc.
- Investigators
- Jason S Slakter, M.D., Principal investigator, Vitreous Retina Macula Consultants of New York, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403442
- Sponsor's protocol ID
- 2303
- Status last verified
- Jul 2008
- First submitted
- 22 Nov 2006
- Last updated
- 30 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
- ClinicalTrials.gov ID
- NCT00403442
- Acronym / sponsor ID
- 2303
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New YorkUniversity, hospital or other
- Collaborators
- QLT Inc.
- Study start
- Sep 2006
- First posted
- 23 Nov 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 purpose of this study is to explore the combination of PDT with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage >50% of total lesion area).
To assess the safety of bevacizumab in combination with verteporfin PDT (reduced fluence: 300 mW/cm2) as compared to bevacizumab in combination with verteporfin PDT (standard fluence: 600 mW/cm2) in patients whose neovascular CNV lesions containing >50% blood.
Detailed description
This is a phase one study in patients with all CNV lesion subtypes who are naïve to previous treatment. Lesions must have blood as a primary component (i.e., contain more than 50% blood). Patients will receive one of two combination treatments:
- Verteporfin PDT reduced fluence (300 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection
- Verteporfin PDT standard fluence (600 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection A total of 10 patients will be enrolled, 5 per treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are men or women of age 50 or older.
- Patients diagnosed with subfoveal CNV due to AMD with lesion size ≤6 DA.
- Patients have not received previous treatment for subfoveal CNV, in the study eye.
- Patients with visual acuities at baseline between 20/40 and 20/320, as evaluated on ETDRS scale.
- Fluorescein Angiography showing any type of subfoveal CNV at baseline with >50% blood component of total lesion area.
Key exclusion criteria (5 listed)
- 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 with history of glaucoma requiring treatment, or are currently on antihypertensive treatment for elevated intraocular pressure.
- Women of childbearing potential must not be pregnant of lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control.
- Patients who have had treatment for CNV in the study eye with photodynamic therapy (PDT), transpupillary thermotherapy (TTT), or other local treatment (e.g. submacular surgery, intravitreal triamcinolone, intra-ocular antiangiogenic agents). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
- Subject's currently who have been 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 Therapy/ Drug: Bevacizumab | Device | – |
Primary outcome
The primary safety variable is visual acuity and adverse events at Month 12.
6 secondary outcomes
Change in percentage of lesion hemorrhage from baseline.
The proportion of patients who lose fewer than 15 letters Less than 3 lines of best corrected visual acuity in the study eye from baseline
The proportion of patients who gain 15 letters or more greater or equal to 3 lines of best-corrected visual acuity in the study eye from baseline
Mean change from baseline in best-corrected visual acuity score. OCT evidence of active CNV leakage which may include persistent retinal edema, subretinal
fluid or pigment epithelial detachment. FA evidence of active CNV leakage which may include subretinal fluid or hemorrhage.
Number of retreatments, bevacizumab and verteporfin PDT, at either fluence rate.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
Jason S Slakter, M.D. principal investigator
Vitreous Retina Macula Consultants of New York, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Verteporfin Therapy/ Drug: Bevacizumab in people with Macular Degeneration, run by Vitreous -Retina- Macula Consultants of New York 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Jul 2008. 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 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.
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 stopped early. Results are not available in the source record.
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?
The primary safety variable is visual acuity and adverse events at Month 12.. 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 30 Jul 2008.