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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02321839

Enrollment

Registered

2014-12-22

Start date

2014-01-31

Completion date

2019-03-31

Last updated

2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration

Keywords

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

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.

Interventions

DRUGIntraviteal Ranibizumab 0.5mg

Intraviteal Ranibizumab 0.5mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Visual acuity	One Year

Secondary

Measure	Time frame
central foveal thickness	One and two years

Other

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026