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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefan Sacu, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01027468
First received: December 7, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention
Neovascular Age-related Macular Degeneration
Drug: Bevacizumab

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Vision [ Time Frame: 3 years after first intravitreal bevacizumab treatment ] [ Designated as safety issue: No ]
  • Vision [ Time Frame: 3 years after initial intravitreal bevacizumab treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systemic Complications After Treatment, Central Retinal Thickness [ Time Frame: 3 years after initial bevacizumab treatment ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: group 1
bevacizumab intravitreal injection
Drug: Bevacizumab
intraocular bevacizumab injection
Other Name: intraocular injection

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01027468

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

No publications provided

Responsible Party: Stefan Sacu, Assoc. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01027468     History of Changes
Other Study ID Numbers: EK 548/2009
Study First Received: December 7, 2009
Results First Received: January 7, 2014
Last Updated: January 7, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
bevacizumab, choroidal neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014