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

• Sponsor: Nagoya City University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02321839
• Collaborator: Novartis (Industry)
• Enrollment: 78
• Locations: 2
• Arm: 1
• Duration (Months): 61.9
• Patients Per Site: 39
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration	Drug: Intraviteal Ranibizumab 0.5mg	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intraviteal Ranibizumab 0.5mg Intraviteal Ranibizumab 0.5mg	Drug: Intraviteal Ranibizumab 0.5mg; Intraviteal Ranibizumab 0.5mg

Outcome Measures

Primary Outcome Measures

1. Visual acuity [One Year]

Secondary Outcome Measures

1. central foveal thickness [One and two years]

Other Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sugita Eye Hospital	Nagoya	Aichi	Japan	460-0008
2	Nagoya City Univsersity	Nagoya	Aichi	Japan	467-8602

Sponsors and Collaborators

• Nagoya City University
• Novartis

Investigators

• Study Chair: Yuichiro Ogura, Nagoya City Univsersity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuichiro Ogura, Professor, Nagoya City University
• ClinicalTrials.gov Identifier: NCT02321839
• Other Study ID Numbers: TAENCU001
• First Posted: Dec 22, 2014
• Last Update Posted: Aug 20, 2019
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yuichiro Ogura, Professor, Nagoya City University: neovascular age-related macular degeneration; Ranibizumab; Treat and extend
• Additional relevant MeSH terms: Macular Degeneration; Wet Macular Degeneration; Ranibizumab

Study Results

No Results Posted as of Aug 20, 2019