Evaluation of the Usefulness of a Treat and Extend Regime... | NCT02321839

Studies
Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular AMD.

NCT02321839

Sponsor

Nagoya City University

Status

Completed

Last Update Posted

Aug 20, 2019Actual

Enrollment

78Actual

Phase

Phase 4

Conditions

Neovascular Age-related Macular Degeneration

Interventions

Intraviteal Ranibizumab 0.5mg

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Mar 2019Actual

Completion Date

Mar 2019Actual

First Submitted Date

Dec 17, 2014

First Submission Date that Met QC Criteria

Dec 19, 2014

First Posted Date

Dec 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2019

Last Update Posted Date

Aug 20, 2019Actual

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Treat and Extend Regimen (TER) may contribute to the improvement to a patients' mentality, since the treatment intervals are extended if there were no signs of recurrence. Therefore, we have planned to examine the psychological impact of TER using Hospital Anxiety and Depression Scale (HADS), in addition to the improvement of visual acuity and central retinal thickness.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intraviteal Ranibizumab 0.5mg	Experimental	Intraviteal Ranibizumab 0.5mg	Drug: Intraviteal Ranibizumab 0.5mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraviteal Ranibizumab 0.5mg	Drug	Intraviteal Ranibizumab 0.5mg	Intraviteal Ranibizumab 0.5mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity		One Year

Secondary Outcomes

Measure	Description	Time Frame
central foveal thickness		One and two years

Other Outcomes

Measure	Description	Time Frame
Hospital Anxiety and Depression Scale	The mean change from baseline in Hospital Anxiety and Depression Scale at week 52 and 104.	one and two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuichiro Ogura	Nagoya City Univsersity	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sugita Eye Hospital		Nagoya	Aichi-ken	460-0008	Japan
Nagoya City Univsersity

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35112307	Derived	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.