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

Nagoya City University

Status and phase: Completed; Phase 4

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Intraviteal Ranibizumab 0.5mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02321839

TAENCU001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

78 participants in 1 patient group

Intraviteal Ranibizumab 0.5mg

Experimental group

Description:

Intraviteal Ranibizumab 0.5mg

Treatment:

Drug: Intraviteal Ranibizumab 0.5mg