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

I

Instituto de Olhos de Goiania

Status and phase

Completed
Phase 4

Conditions

Age Related Macular Degeneration

Treatments

Drug: bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00556348
JN-02-2007-ARVO

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

1
Experimental group
Treatment:
Drug: bevacizumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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