ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327222
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : April 1, 2011
Sponsor:
Information provided by:
IRCCS San Raffaele

Brief 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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: Bevacizumab Phase 3

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. change in best-corrected visual acuity [ Time Frame: 6 months ]
    change in best-corrected visual acuity at the end of the follow-up


Secondary Outcome Measures :
  1. change in central macular thickness [ Time Frame: 6 months ]
    change in central macular thickness on OCT

  2. NEI VFQ-25 scores [ Time Frame: 6 months ]
    change in NEI VFQ-25 scores questionnaire



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Vision, Low
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents