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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01027468
Recruitment Status : Completed
First Posted : December 8, 2009
Results First Posted : February 20, 2014
Last Update Posted : April 24, 2019
Information provided by (Responsible Party):
Stefan Sacu, 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).

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: Bevacizumab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up
Study Start Date : August 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: group 1
bevacizumab intravitreal injection
Drug: Bevacizumab
intraocular bevacizumab injection
Other Name: intraocular injection

Primary Outcome Measures :
  1. 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

  2. CRT (Central Retinal Thickness) [ Time Frame: 3 years after initial intravitreal bevacizumab treatment ]
    Central retinal thickness measured in µm

Secondary Outcome Measures :
  1. Systemic Complications After Treatment [ Time Frame: 3 years after initial bevacizumab treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01027468

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

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Responsible Party: Stefan Sacu, Assoc. Prof. Dr., Medical University of Vienna Identifier: NCT01027468    
Other Study ID Numbers: EK 548/2009
First Posted: December 8, 2009    Key Record Dates
Results First Posted: February 20, 2014
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by Stefan Sacu, Medical University of Vienna:
bevacizumab, choroidal neovascularization
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors