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

NCT ID: NCT02321839

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neovascular Age-related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intraviteal Ranibizumab 0.5mg

Intraviteal Ranibizumab 0.5mg

Group Type EXPERIMENTAL

Intraviteal Ranibizumab 0.5mg

Intervention Type DRUG

Intraviteal Ranibizumab 0.5mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraviteal Ranibizumab 0.5mg

Intraviteal Ranibizumab 0.5mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis

INDUSTRY

Sponsor Role collaborator

Nagoya City University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yuichiro Ogura

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuichiro Ogura

Role: STUDY_CHAIR

Nagoya City Univsersity

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sugita Eye Hospital

Nagoya, Aichi-ken, Japan

Site Status

Nagoya City Univsersity

Nagoya, Aichi-ken, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35112307 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAENCU001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.