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

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556348
• Other study ID #: JN-02-2007-ARVO
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2007
• Last updated: November 19, 2011
• Start date: November 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2011
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• bevacizumab
1.25mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP			Yes
Secondary	Ocular side effects (infection, RD, IOP rise, cataract)