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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT00556348
First received: November 9, 2007
Last updated: November 19, 2011
Last verified: November 2011
History of Changes

November 9, 2007
November 19, 2011
November 2005
October 2007   (final data collection date for primary outcome measure)
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP [ Designated as safety issue: Yes ]
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP
Complete list of historical versions of study NCT00556348 on ClinicalTrials.gov Archive Site
Ocular side effects (infection, RD, IOP rise, cataract)
Same as current
Not Provided
Not Provided
 
Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

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.

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.
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Age Related Macular Degeneration
Drug: bevacizumab
1.25mg
Experimental: 1
Intervention: Drug: bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
November 2008
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00556348
JN-02-2007-ARVO
Yes
Joao Nassaralla, Instituto de Olhos de Goiania
Instituto de Olhos de Goiania
Not Provided
Principal Investigator: Joao J Nassaralla, Jr UnB and IOG
Instituto de Olhos de Goiania
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP