Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

Official title:

Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032109
• Other study ID #: PCBK610
• Status: Completed
• Phase: N/A
• First received: December 12, 2009
• Last updated: February 25, 2016
• Start date: October 2006
• Est. completion date: May 2008

Study information

• Verified date: February 2016
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare 12-month results of two single initial treatments—photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab—for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• choroidal neovascularization caused by age-related macula degeneration

• no previous treatment

• a follow-up at least 12 months

• a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart

Exclusion Criteria:

• choroidal neovascularization caused by other eye diseases

• ocular surgery within the past 3 mouths

• history of uveitis

• intraocular pressure higher than 25 mmHg, or glaucoma

• history of systemic or ocular thromboembolic events.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Bevacizumab
A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.

Locations

Country	Name	City	State
Japan	Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		The comparison between baseline and 12-month	No