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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Instituto de Olhos de Goiania.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: Ranibizumab (Intravitreal injection)
Drug: Bevacizumab (Intravitreal injection)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Instituto de Olhos de Goiania:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 500
Study Start Date: March 2009
Estimated Study Completion Date: February 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranibizumab
Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)
Drug: Ranibizumab (Intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Active Comparator: Bevacizumab
Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)
Drug: Bevacizumab (Intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014468

Locations
Brazil
Instituto de Olhos de Goiânia
Goiânia, Goiás, Brazil, 74110-120
Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Study Chair: João J Nassaralla, Jr IOG and UnB
  More Information

No publications provided

Responsible Party: Joao Nassaralla, Medical Doctor, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT01014468     History of Changes
Other Study ID Numbers: JJNJ - 8 - 2009
Study First Received: November 16, 2009
Last Updated: November 19, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Olhos de Goiania:
ranibizumab
bevacizumab
AMD
Complications
Visual acuity
OCt
Age Macular Degeneration

Additional relevant MeSH terms:
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 21, 2014