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

April 3, 2019 updated by: Stefan Sacu, Medical University of Vienna

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
bevacizumab intravitreal injection
Drug: Bevacizumab
intraocular bevacizumab injection
Other Names:
  • intraocular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years after first intravitreal bevacizumab treatment
CRT (Central Retinal Thickness)
Time Frame: 3 years after initial intravitreal bevacizumab treatment
Central retinal thickness measured in µm
3 years after initial intravitreal bevacizumab treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Systemic Complications After Treatment
Time Frame: 3 years after initial bevacizumab treatment
3 years after initial bevacizumab treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Stefan Sacu, PD Dr., Department of Ophthalmology, Medical University of Vienna, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 8, 2009

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 548/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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