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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

Tracking Information
First Submitted Date  ICMJE December 7, 2009
First Posted Date  ICMJE December 8, 2009
Results First Submitted Date January 7, 2014
Results First Posted Date February 20, 2014
Last Update Posted Date February 20, 2014
Study Start Date  ICMJE August 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2012)
  • Vision [ Time Frame: 3 years after first intravitreal bevacizumab treatment ]
  • Vision [ Time Frame: 3 years after initial intravitreal bevacizumab treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2009)
  • Visual acuity (Snellen 6m) Central retinal thickness (Stratus OCT; Cirrus OCT) [ Time Frame: 3 years after first intravitreal bevacizumab treatment ]
  • best-corrected visual acuity (Snellen 6m) central retinal thickness (Stratus OCT; Cirrus OCT) [ Time Frame: 3 years after initial intravitreal bevacizumab treatment ]
Change History Complete list of historical versions of study NCT01027468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2012)
Systemic Complications After Treatment, Central Retinal Thickness [ Time Frame: 3 years after initial bevacizumab treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2009)
systemic complications after treatment [ Time Frame: 3 years after initial bevacizumab treatment ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration
Official Title  ICMJE Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up
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 Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE Drug: Bevacizumab
intraocular bevacizumab injection
Other Name: intraocular injection
Study Arms No Intervention: group 1
bevacizumab intravitreal injection
Intervention: Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2009)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 sytemic disease
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01027468
Other Study ID Numbers  ICMJE EK 548/2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stefan Sacu, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Sacu, PD Dr. Department of Ophthalmology, Medical University of Vienna, Austria
PRS Account Medical University of Vienna
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP