Age-related Macular DegenerationNCT01032109
Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration
A study testing Bevacizumab in people with Age-related Macular Degeneration, run by Kumamoto University at 1 site in Japan.
Trial summary
The purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2006to May 2008
- Phase
- Interventional
- 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
- choroidal neovascularization caused by age-related macula degeneration
- no previous treatment
- a follow-up at least 12 months
- a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart
Who cannot join
- choroidal neovascularization caused by other eye diseases
- ocular surgery within the past 3 mouths
- history of uveitis
- intraocular pressure higher than 25 mmHg, or glaucoma
- history of systemic or ocular thromboembolic events.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, 860-8556
About this study
Official title: Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration
The purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Bevacizumab
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: The comparison between baseline and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startOct 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takahiro Kawaji, Kumamoto University
- Investigators
- Takahiro Kawaji, MD, PhD, Principal investigator, Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032109
- Sponsor's protocol ID
- PCBK610
- Status last verified
- Feb 2016
- First submitted
- 12 Dec 2009
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hara R, Kawaji T, Inomata Y, Tahara J, Sagara N, Fukushima M, Tanihara H. Photodynamic therapy alone versus combined with intravitreal bevacizumab for neovascular age-related macular degeneration without polypoidal choroidal vasculopathy in Japanese patients. Graefes Arch Clin Exp Ophthalmol. 2010 Jul;248(7):931-6. doi: 10.1007/s00417-010-1343-8. Epub 2010 Mar 10.
PubMed 20221623
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01032109
- Acronym / sponsor ID
- PCBK610
- Conditions
- Age-related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Dec 2009 (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 compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- choroidal neovascularization caused by age-related macula degeneration
- no previous treatment
- a follow-up at least 12 months
- a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart
Key exclusion criteria (5 listed)
- choroidal neovascularization caused by other eye diseases
- ocular surgery within the past 3 mouths
- history of uveitis
- intraocular pressure higher than 25 mmHg, or glaucoma
- history of systemic or ocular thromboembolic events.
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 |
|---|---|---|
| BevacizumabAlso: AvastinA single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment. | Drug | Bevacizumab |
Primary outcome
Visual acuity
Time frame: The comparison between baseline and 12-month
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 Feb 2016.
- Derived from this study: PubMed 20221623Hara R, Kawaji T, Inomata Y, Tahara J, Sagara N, Fukushima M, Tanihara H. Photodynamic therapy alone versus combined with intravitreal bevacizumab for neovascular age-related macular degeneration without polypoidal choroidal vasculopathy in Japanese patients. Graefes Arch Clin Exp Ophthalmol. 2010 Jul;248(7):931-6. doi: 10.1007/s00417-010-1343-8. Epub 2010 Mar 10.
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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.
Takahiro Kawaji, MD, PhD principal investigator
Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab in people with Age-related Macular Degeneration, run by Kumamoto University at 1 site in Japan.
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 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: finished, as of the sponsor's last update on 26 Feb 2016. 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 Japan. 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.
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 acuity (time frame: The comparison between baseline and 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032109, which also lists 1 linked publication.
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 Feb 2016.