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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Intraviteal Ranibizumab 0.5mg

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring neovascular age-related macular degeneration, Ranibizumab, Treat and extend

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sugita Eye Hospital
Nagoya City Univsersity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraviteal Ranibizumab 0.5mg

Arm Description

Intraviteal Ranibizumab 0.5mg

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

central foveal thickness

Full Information

NCT ID

NCT02321839

First Posted

December 17, 2014

Last Updated

August 17, 2019

Sponsor

Nagoya City University

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT02321839

Brief Title

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

Official Title

Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

March 2019 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nagoya City University

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Age-related Macular Degeneration

Keywords

neovascular age-related macular degeneration, Ranibizumab, Treat and extend

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intraviteal Ranibizumab 0.5mg

Arm Type

Experimental

Arm Description

Intraviteal Ranibizumab 0.5mg

Intervention Type

Drug

Intervention Name(s)

Intraviteal Ranibizumab 0.5mg

Intervention Description

Intraviteal Ranibizumab 0.5mg

Primary Outcome Measure Information:

Title

Visual acuity

Time Frame

One Year

Secondary Outcome Measure Information:

Title

central foveal thickness

Time Frame

One and two years

Other Pre-specified Outcome Measures:

Title

Hospital Anxiety and Depression Scale

Description

The mean change from baseline in Hospital Anxiety and Depression Scale at week 52 and 104.

Time Frame

one and two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuichiro Ogura

Organizational Affiliation

Nagoya City Univsersity

Official's Role

Study Chair

Facility Information:

Facility Name

Sugita Eye Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0008

Country

Japan

Facility Name

Nagoya City Univsersity

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35112307

Citation

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.

Results Reference

derived

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

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