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Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

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: NCT00556348
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: bevacizumab Phase 4

Detailed Description:
We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
Study Start Date : November 2005
Primary Completion Date : October 2007
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: bevacizumab
1.25mg


Outcome Measures

Primary Outcome Measures :
  1. Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP

Secondary Outcome Measures :
  1. Ocular side effects (infection, RD, IOP rise, cataract)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
  • Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
  • Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
  • Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.

Exclusion Criteria:

  • Patients with poor compliance
  • Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients).
  • Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
Contacts and Locations

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): NCT00556348


Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Principal Investigator: Joao J Nassaralla, Jr UnB and IOG
More Information

Responsible Party: Joao Nassaralla, MD, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT00556348     History of Changes
Other Study ID Numbers: JN-02-2007-ARVO
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Joao Nassaralla, Instituto de Olhos de Goiania:
bevacizumab
AMD
Complications
Visual acuity
OCt
Age Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents