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

This study has been completed.
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania Identifier:
First received: November 9, 2007
Last updated: November 19, 2011
Last verified: November 2011
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 Intervention Phase
Age Related Macular Degeneration
Drug: bevacizumab
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

Resource links provided by NLM:

Further study details as provided by Joao Nassaralla, Instituto de Olhos de Goiania:

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

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

Enrollment: 500
Study Start Date: November 2005
Study Completion Date: November 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab

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.

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

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.
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Please refer to this study by its identifier: NCT00556348

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

Responsible Party: Joao Nassaralla, MD, Instituto de Olhos de Goiania Identifier: NCT00556348     History of Changes
Other Study ID Numbers: JN-02-2007-ARVO
Study First Received: November 9, 2007
Last Updated: November 19, 2011

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

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on May 25, 2017