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

This study has been completed.

Sponsored by: Instituto de Olhos de Goiania
Information provided by: Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT00556348
  Purpose

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 IV

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Macular Degeneration   

ChemIDplus related topics:   Bevacizumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

Further study details as provided by 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)

Estimated Enrollment:   500
Study Start Date:   November 2005
Study Completion Date:   November 2007

Arms Assigned Interventions
1: Experimental Drug: bevacizumab
1.25mg

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556348

Sponsors and Collaborators
Instituto de Olhos de Goiania

Investigators
Principal Investigator:     Joao J Nassaralla, Jr     UnB and IOG    
  More Information


Study ID Numbers:   JN-02-2007-ARVO
First Received:   November 9, 2007
Last Updated:   November 9, 2007
ClinicalTrials.gov Identifier:   NCT00556348
Health Authority:   Brazil: National Health Surveillance Agency

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

Study placed in the following topic categories:
Metaplasia
Eye Diseases
Neoplasm Metastasis
Retinal Degeneration
Macular Degeneration
Bevacizumab
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Pathologic Processes
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




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