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

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).

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Key information

Conditions

Neovascular Age-related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

intraocular bevacizumab injection

Other names: intraocular injection

Primary outcomes

Vision

Time frame: 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)

Time frame: 3 years after initial intravitreal bevacizumab treatment

Central retinal thickness measured in µm

Secondary outcomes

Systemic Complications After Treatment

Time frame: 3 years after initial bevacizumab treatment

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Dec 8, 2009
Registry last updated: Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed