Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration

Not Applicable

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01027468
• Lead Sponsor: Medical University of Vienna

Brief Summary

200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).

Detailed Description

In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-08
• Results First Submitted: 2014-01-07
• Results First Submitted QC: 2014-01-07
• Results First Posted: 2014-02-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• any subtype of neovascular age-related macular degeneration
• age of 50 years or older
• initial treatment with intravitreal bevacizumab between August 2005 and June 2006

Exclusion Criteria

• previous vitrectomy
• presence of cystoid macular edema without choroidal neovascularization
• Uncontrolled systemic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group 1	Bevacizumab	bevacizumab intravitreal injection

Primary Outcome Measures

Name	Time	Method
Vision	3 years after first intravitreal bevacizumab treatment	Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis
CRT (Central Retinal Thickness)	3 years after initial intravitreal bevacizumab treatment	Central retinal thickness measured in µm

Secondary Outcome Measures

Name	Time	Method
Systemic Complications After Treatment	3 years after initial bevacizumab treatment