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

This study has been completed.
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01327222
First received: March 30, 2011
Last updated: March 31, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: Bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • change in best-corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change in best-corrected visual acuity at the end of the follow-up


Secondary Outcome Measures:
  • change in central macular thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change in central macular thickness on OCT

  • NEI VFQ-25 scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change in NEI VFQ-25 scores questionnaire


Enrollment: 20
Study Start Date: February 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bevacizumab
three-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography
Drug: Bevacizumab
1.25 mg intravitreal bevacizumab
Other Name: avastin
No Intervention: control
monthly follow-up

Detailed 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

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327222

Locations
Italy
IRCCS San Raffaele
Milano, MI, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Study Chair: Francesco Bandello, MD Department of Ophthalmology
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Bandello, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01327222     History of Changes
Other Study ID Numbers: LOW-VISION
Study First Received: March 30, 2011
Last Updated: March 31, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS San Raffaele:
age-related macular degeneration
bevacizumab

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014