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Clinical Trials/NCT00556348
NCT00556348
Completed
Phase 4

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

Instituto de Olhos de Goiania0 sites500 target enrollmentNovember 2005

Overview

Phase
Phase 4
Intervention
bevacizumab
Conditions
Age Related Macular Degeneration
Sponsor
Instituto de Olhos de Goiania
Enrollment
500
Primary Endpoint
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP
Status
Completed
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
November 2008
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Instituto de Olhos de Goiania
Responsible Party
Principal Investigator
Principal Investigator

Joao Nassaralla

MD

Instituto de Olhos de Goiania

Eligibility 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.

Arms & Interventions

1

Intervention: bevacizumab

Outcomes

Primary Outcomes

Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP

Secondary Outcomes

  • Ocular side effects (infection, RD, IOP rise, cataract)

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