Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)

Age Related Macular Degeneration Clinical Trial

— LOW-VISION  

Official title:

Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327222
• Other study ID #: LOW-VISION
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2011
• Last updated: March 31, 2011
• Start date: February 2011
• Est. completion date: February 2011

Study information

• Verified date: January 2011
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Description:

There is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements.

Aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

Inclusion Criteria:

• age-related macular degeneration

• naïve subfoveal choroidal neovascularization

• best-corrected visual acuity less then 20/200

Exclusion Criteria:

• previous treatments

• any other condition able to limit the visual improvement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Bevacizumab
1.25 mg intravitreal bevacizumab

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Arevalo JF, Sánchez JG, Wu L, Berrocal MH, Alezzandrini AA, Restrepo N, Maia M, Farah ME, Brito M, Díaz-Llopis M, Rodríguez FJ, Reategui G, Iturralde-Iraola J, Udaondo-Mirete P; Pan-American Collaborative Retina Study Group. Intravitreal bevacizumab for subfoveal choroidal neovascularization in age-related macular degeneration at twenty-four months: the Pan-American Collaborative Retina Study. Ophthalmology. 2010 Oct;117(10):1974-81, 1981.e1. doi: 10.1016/j.ophtha.2010.01.056. Epub 2010 May 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in best-corrected visual acuity	change in best-corrected visual acuity at the end of the follow-up	6 months	No
Secondary	change in central macular thickness	change in central macular thickness on OCT	6 months	No
Secondary	NEI VFQ-25 scores	change in NEI VFQ-25 scores questionnaire	6 months	No