Visual Disorder Due to Age-related Macula DegenerationQUATRONCT02158624
Ranibizumab Treatment for Age-Related Macular Degeneretion
A study testing Intravitreal Lucentis 0.5mg in people with Visual Disorder Due to Age-related Macula Degeneration, run by Kyushu University at 1 site in Japan.
Trial summary
To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Visual Disorder Due to Age-related Macula Degeneration
- What is being tested?
- Intravitreal Lucentis 0.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2013to Dec 2015
- 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
- Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
- Subjects of either gender age 50 years or older
- Visual acuity better than 0.05 decimal( 20/400 Snellen)
- Signed informed consent form
Who cannot join
- Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
- Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
- Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
- Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
- Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
- The pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Kyushu University Hospital
Maidashi, Higashiku, Fukuoka-city, Fukuoka, 812-8582
Yuji Oshima, MD. PhD, +81-92-642-5648, yuji@eye.med.kyushu-u.ac.jp
About this study
Official title: The Correlation for Improvement of Visual Acuity and QOL After Ranibizmab Treatment for Age-Related Macular Degeneration Patients
To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.
- Being tested
- Intravitreal Lucentis 0.5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Lucentis 0.5mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Not described Receives: Drug: Intravitreal Lucentis 0.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline change of visual acuity and QOL after ranibizumab treatment
Analyze the correlation between visual acuity improvement and QOL assessment using VFQ-25 and Patient Satisfaction Questionnaire before and after initial ranibizumab treatment for AMD patients.
Measured: 3 months
Secondary outcomes (1)
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Disorder Due to Age-related Macula 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyushu University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Occupational and Environmental Health, Kurume University, Fukuoka University, Clinical Research Support Center Kyush, Novartis
- Responsible party
- Principal investigator, Yuji Oshima, Kyushu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158624
- Sponsor's protocol ID
- 13-E-09
- Acronym
- QUATRO
- Status last verified
- Jun 2014
- First submitted
- 5 Jun 2014
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation for Improvement of Visual Acuity and QOL After Ranibizmab Treatment for Age-Related Macular Degeneration Patients
- ClinicalTrials.gov ID
- NCT02158624
- Acronym / sponsor ID
- QUATRO / 13-E-09
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kyushu UniversityUniversity, hospital or other
- Collaborators
- University of Occupational and Environmental Health, Kurume University, Fukuoka University, Clinical Research Support Center Kyush, Novartis
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Jun 2014 (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.
To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Intravitreal Lucentis 0.5mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
- Subjects of either gender age 50 years or older
- Visual acuity better than 0.05 decimal( 20/400 Snellen)
- Signed informed consent form
Key exclusion criteria (6 listed)
- Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
- Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
- Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
- Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
- Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
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 |
|---|---|---|
| Intravitreal Lucentis 0.5mg | Drug | Ranibizumab |
Primary outcome
Baseline change of visual acuity and QOL after ranibizumab treatment
Time frame: 3 months
Analyze the correlation between visual acuity improvement and QOL assessment using VFQ-25 and Patient Satisfaction Questionnaire before and after initial ranibizumab treatment for AMD patients.
1 secondary outcome
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Related trials for Visual Disorder Due to Age-related Macula Degeneration
Active, not recruitingObservational study
The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema
Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal Lucentis 0.5mg in people with Visual Disorder Due to Age-related Macula Degeneration, run by Kyushu 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 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatsuro Ishibashi, MD. PhD (+81-92-642-5648, ishi@eye.med.kyushu-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline change of visual acuity and QOL after ranibizumab treatment (time frame: 3 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 9 Jun 2014.