Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

NCT00556348 | Completed Phase 4 DMC

• 1 other identifier: JN-02-2007-ARVO
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.

Conditions

Age Related Macular Degeneration

Keywords

bevacizumab; AMD; Complications; Visual acuity; OCt; Age Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP

Secondary Outcomes (1)

• Ocular side effects (infection, RD, IOP rise, cataract)

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab

Interventions

bevacizumab DRUG

1.25mg

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
• Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
• Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
• Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.

You may not qualify if:

• Patients with poor compliance
• Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
• Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.

Sponsors & Collaborators

• Instituto de Olhos de Goiania: lead

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joao J Nassaralla, Jr

  UnB and IOG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: November 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2008
• Last Updated: November 22, 2011

Record last verified: 2011-11