NCT02321839

Brief Summary

To evaluate the visual outcome, number of injections and visits, and the effect of mental status of a treat and extend regimen in managing neovascular age-related macular degeneration with intravitreal ranibizumab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

January 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 20, 2019

Status Verified

October 1, 2016

Enrollment Period

5.2 years

First QC Date

December 17, 2014

Last Update Submit

August 17, 2019

Conditions

Neovascular Age-related Macular Degeneration

Keywords

neovascular age-related macular degenerationRanibizumabTreat and extend

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    One Year

Secondary Outcomes (1)

  • central foveal thickness

    One and two years

Other Outcomes (1)

  • Hospital Anxiety and Depression Scale

    one and two years

Study Arms (1)

Intraviteal Ranibizumab 0.5mg

EXPERIMENTAL

Intraviteal Ranibizumab 0.5mg

Drug: Intraviteal Ranibizumab 0.5mg

Interventions

Intraviteal Ranibizumab 0.5mgDRUG

Intraviteal Ranibizumab 0.5mg

Intraviteal Ranibizumab 0.5mg

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent form
  • Male or female of aged 50 years or older
  • Typical AMD and PCV patients
  • BCVA of 24 letters or over

You may not qualify if:

  • Total lesion area of \>12 DA or \>30.5 mm2
  • The existence of subretinal hemorrhage area constituting ≥50% of total lesion area
  • The existence of scar or fibrosis area constituting ≥50% of total lesion area
  • The existence of RPE tear
  • Prior treatment for wet AMD
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • The pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sugita Eye Hospital

Nagoya, Aichi-ken, 460-0008, Japan

Location

Nagoya City Univsersity

Nagoya, Aichi-ken, 467-8602, Japan

Location

Related Publications (1)

  • Kato A, Yasukawa T, Sugita I, Yoshida M, Nozaki M, Hirano Y, Kondo J, Abe T, Sugita K, Okita T, Morita H, Takase N, Ogura Y. Mental Status and Feasibility of an Intravitreal Ranibizumab Treat-and-Extend Regimen in Patients with Neovascular Age-Related Macular Degeneration. Adv Ther. 2022 Mar;39(3):1403-1416. doi: 10.1007/s12325-022-02052-1. Epub 2022 Feb 3.

    PMID: 35112307DERIVED

Study Officials

  • Yuichiro Ogura

    Nagoya City Univsersity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

August 20, 2019

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)