NCT02158624

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 9, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

June 5, 2014

Last Update Submit

June 5, 2014

Conditions

Visual Disorder Due to Age-related Macula Degeneration

Outcome Measures

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.

    3 months

Secondary Outcomes (1)

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

    1year

Other Outcomes (1)

  • Baseline change of central retinal thickness by OCT examination.

    3 months, 1 year

Study Arms (1)

Ranibizumab

EXPERIMENTAL
Drug: Intravitreal Lucentis 0.5mg

Interventions

Intravitreal Lucentis 0.5mgDRUG
Ranibizumab

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Kyushu University Hospital

Maidashi, Higashiku, Fukuoka-city, Fukuoka, 812-8582, Japan

RECRUITING

Central Study Contacts

Tatsuro Ishibashi, MD. PhD

CONTACT

+81-92-642-5648ishi@eye.med.kyushu-u.ac.jp

Yuji Oshima, MD. PhD

CONTACT

+81-92-642-5648yuji@eye.med.kyushu-u.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 9, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2015

Study Completion

December 1, 2015

Last Updated

June 9, 2014

Record last verified: 2014-06

Locations

JP(1)