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Status unknownNCT02158624QUATROUpdated Jun 9, 2014

Ranibizumab Treatment for Age-Related Macular Degeneretion

An interventional study of Intravitreal Lucentis 0.5mg in Visual Disorder Due to Age-related Macula Degeneration, sponsored by Kyushu University. Status unknown at 1 site in Japan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-06-09.

Sponsored by Kyushu University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Visual Disorder Due to Age-related Macula Degeneration

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03

In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 211 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Kyushu University is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Ranibizumab

    Drug: Intravitreal Lucentis 0.5mg

Interventions

  • DrugIntravitreal Lucentis 0.5mg
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations

    Time frame: 1year

Other outcomes

  1. Baseline change of central retinal thickness by OCT examination.

    Time frame: 3 months, 1 year

07

Study locations

1 of 1 sites recruiting
  • Department of Ophthalmology, Kyushu University Hospital
    Maidashi, Higashiku, Fukuoka-city, Fukuoka 812-8582, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02158624
Lead sponsor
Kyushu University
Collaborators
University of Occupational and Environmental Health, Kurume University, Fukuoka University, Clinical Research Support Center Kyush, Novartis
Responsible party
Yuji Oshima (Assistant professor, Kyushu University) — Principal investigator
First posted
Jun 9, 2014
Start date
Dec 2013
Primary completion
Apr 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Jun 9, 2014

Study contacts

Tatsuro Ishibashi, MD. PhD
Contact
ishi@eye.med.kyushu-u.ac.jp
+81-92-642-5648
Yuji Oshima, MD. PhD
Contact
yuji@eye.med.kyushu-u.ac.jp
+81-92-642-5648

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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