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

Phase 4

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: bevacizumab

• Registration Number: NCT00556348
• Lead Sponsor: Instituto de Olhos de Goiania

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.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-10
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Study Completion: 2008-11
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-19
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	bevacizumab	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ocular side effects (infection, RD, IOP rise, cataract)