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

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ClinicalTrials.gov Identifier: NCT01027468
Recruitment Status : Completed
First Posted : December 8, 2009
Results First Posted : February 20, 2014
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Stefan Sacu, Medical University of Vienna

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neovascular Age-related Macular Degeneration
Intervention Drug: Bevacizumab
Enrollment 160
Recruitment Details Medical University of Vienna, Department of Ophthalmology during September 2008-July 2009 with a mean of 3 year follow-up after initial Bevacizumab intravitreal treatment
Pre-assignment Details

Inclusion criteria:

  • patients treated with bevacizumab due to wet age-related macular degeneration
  • follow-up of 3 years

Exclusion criteria:

- patients with other macular diseases

Arm/Group Title Group 1
Hide Arm/Group Description 3 year follow-up of patients with intravitreal application of bevacizumab
Period Title: Overall Study
Started 160
Completed 160
Not Completed 0
Arm/Group Title Group 1
Hide Arm/Group Description 3 year follow-up of intravitreal application of bevacizumab
Overall Number of Baseline Participants 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants
77.24  (10.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Female
102
  63.7%
Male
58
  36.3%
1.Primary Outcome
Title Vision
Hide Description [Not Specified]
Time Frame 3 years after first intravitreal bevacizumab treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
Hide Arm/Group Description:
3 year follow-up of intravitreal application of bevacizumab
Overall Number of Participants Analyzed 160
Mean (Standard Deviation)
Unit of Measure: logMar
0.16  (0.21)
2.Primary Outcome
Title Vision
Hide Description [Not Specified]
Time Frame 3 years after initial intravitreal bevacizumab treatment
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Systemic Complications After Treatment, Central Retinal Thickness
Hide Description [Not Specified]
Time Frame 3 years after initial bevacizumab treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description 3 year follow-up of intravitreal application of bevacizumab
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   5/160 (3.13%) 
Eye disorders   
intraocular inflammation   5/160 (3.13%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/160 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Assoc.Prof.PD.Dr.Stefan Sacu
Organization: Medical University of Vienna
Phone: +43404001 ext 7937
Responsible Party: Stefan Sacu, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01027468     History of Changes
Other Study ID Numbers: EK 548/2009
First Submitted: December 7, 2009
First Posted: December 8, 2009
Results First Submitted: January 7, 2014
Results First Posted: February 20, 2014
Last Update Posted: February 20, 2014