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Ranibizumab Treatment for Age-Related Macular Degeneretion

The Correlation for Improvement of Visual Acuity and QOL After Ranibizmab Treatment for Age-Related Macular Degeneration Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02158624
Acronym
QUATRO
Enrollment
100
Registered
2014-06-09
Start date
2013-12-31
Completion date
2015-12-31
Last updated
2014-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Disorder Due to Age-related Macula Degeneration

Brief summary

To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.

Interventions

DRUGIntravitreal Lucentis 0.5mg

Sponsors

University of Occupational and Environmental Health
CollaboratorOTHER
Kurume University
CollaboratorOTHER
Fukuoka University
CollaboratorOTHER
Clinical Research Support Center Kyush
CollaboratorOTHER
Novartis
CollaboratorINDUSTRY
Kyushu University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Baseline change of visual acuity and QOL after ranibizumab treatment3 monthsAnalyze 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.

Secondary

MeasureTime frame
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations1year

Other

MeasureTime frame
Baseline change of central retinal thickness by OCT examination.3 months, 1 year

Countries

Japan

Contacts

Primary ContactTatsuro Ishibashi, MD. PhD
ishi@eye.med.kyushu-u.ac.jp+81-92-642-5648
Backup ContactYuji Oshima, MD. PhD
yuji@eye.med.kyushu-u.ac.jp+81-92-642-5648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026