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

Sponsor

Instituto de Olhos de Goiania (Other)

Overall Status

Completed

CT.gov ID

NCT00556348

Collaborator

(none)

500

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: bevacizumab	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: bevacizumab 1.25mg

Arm

Intervention/Treatment

Experimental: 1

Drug: bevacizumab

1.25mg

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.