Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration (AxL-2009)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Joao Nassaralla, Instituto de Olhos de Goiania

ClinicalTrials.gov Identifier:

NCT01014468

First received: November 16, 2009

Last updated: November 19, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 16, 2009

Last Updated Date

November 19, 2011

Start Date ^ICMJE

March 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP ) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01014468 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ocular side effects (infection, RD, IOP rise, cataract) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Official Title ^ICMJE

Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Brief Summary

To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to age-related macular degeneration.

Detailed Description

We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab and had a follow-up of at least 3 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Age Related Macular Degeneration

Intervention ^ICMJE

Drug: Ranibizumab (Intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Drug: Bevacizumab (Intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Study Arm (s)

Active Comparator: Ranibizumab
Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)

Intervention: Drug: Ranibizumab (Intravitreal injection)
Active Comparator: Bevacizumab
Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)

Intervention: Drug: Bevacizumab (Intravitreal injection)

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

Active, not recruiting

Enrollment ^ICMJE

500

Estimated Completion Date

February 2012

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age ≥ 50 years
Active primary or recurrent subfoveal lesion with CNV secondary to AMD

Exclusion Criteria:

Prior treatment with any intravitreal drug in the study eye
Prior treatment with verteporfin photodynamic therapy in the study eye
Prior treatment with systemic bevacizumab
Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
Laser photocoagulation within 1 month before study entry in the study eye
Previous participation in any clinical trial within 1 month before the entry of the study
Subfoveal fibrosis or atrophy in the study eye
CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia
Retinal pigment epithelial tear involving the macula in the study eye
Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
Active intraocular inflammation
Vitreous hemorrhage in the study eye

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01014468

Other Study ID Numbers ^ICMJE

JJNJ - 8 - 2009

Has Data Monitoring Committee

Yes

Responsible Party

Joao Nassaralla, Instituto de Olhos de Goiania

Study Sponsor ^ICMJE

Instituto de Olhos de Goiania

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

João J Nassaralla, Jr

IOG and UnB

Information Provided By

Instituto de Olhos de Goiania

Verification Date

November 2011

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

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