Bevicizumab (Avastin) Infusion for Choroidal Neovascularization (CNV) Not Associated With Age-Related Macular Degeneration (AMD)

NCT00407719 | Completed Phase 1

• 2 other identifiers: FVF 368705-05-16-06
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see if the drug bevacizumab is safe and effective to use for people with choroidal neovascularization (CNV). CNV is an eye condition where abnormal blood vessels grow in the part of the eye responsible for central (straight ahead) vision. The drug is produced using recombinant DNA technology and has been approved by the FDA for use in colon cancer. Although not yet approved for people with CNV, the FDA has given permission to use this drug in this study.

Conditions

Choroidal Neovascularization; Degenerative Myopia; Pathological Myopia

Keywords

Choroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

• Visual acuity: In this pilot study, the sample size is not powered for clinical response. However, preliminary data on visual acuity will aid in the design of future randomized control trial.

  each visit for study duration up to 24 mos

Secondary Outcomes (2)

• Retinal thickness assessed by OCT

  each visit

• CNV leakage assessed by Digital Fluorescein Angiography

  per protocol

Interventions

Bevacizumab DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (ECG)at least 28 days prior to entry into the study must show no evidence of current or prior myocardial ischemia, infarction, or significant arrhythmia.
• Adequate bone marrow function:
• Absolute granulocyte count (neutrophils and bands) \> 1500 cells/mm3;
• Platelet count \> 100,000 cells/mm3;
• g/dL; 9) PT/PTT within the institution upper limit of Hemoglobin, normal (ULN) or INR \<1.1. 10) Adequate renal function: serum creatinine ≤ 2.0 mg/dL. 11)Patients of child bearing potential must abstain from sexual intercourse or use effective birth control. Negative serum pregnancy test result confirmation prior to treatment.
• Patients must be able to return for all study visits within required visit windows.
• Patients must provide written informed consent

You may not qualify if:

• Previous subfoveal thermal laser therapy.
• Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss.
• Significant media opacities, including cataract, which can interfere with visual acuity, assessment of toxicity, or fundus photography.
• Any intraocular surgery in the study eye within 12 weeks of entry.
• If the CNV in the study eye has been treated with photodynamic therapy (PDT), the treatment must be at least 12 weeks prior to study entry, unless it is judged by the investigator that the ocular disease has deteriorated within the 12-week period
• Any treatment for CNV in the study eye with anti-vascular endothelial growth factor (anti-VEGF) therapy, intraocularly or intravenously, must be at least 6 weeks prior to study entry, unless it is judged that the ocular disease has deteriorated within the 6-week period
• Uncontrolled hypertension defined as blood pressure consistently (at 3 or more consecutive visits) greater than 150/100 irrespective or medication.
• Any history, physical signs, or EKG findings suggesting significant heart disease.
• History of thromboembolism or stroke.
• History, physical signs, or laboratory of bleeding diathesis or coagulopathy. Any history (within 3 years) of significant gastrointestinal, oral (gum), or nasal bleeding..
• History or physical signs of peripheral vascular disease.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to entry.
• Anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to entry.
• Women who are pregnant (positive pregnancy test) or breastfeeding.

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (1)

• Nguyen QD, Shah SM, Hafiz G, Do DV, Haller JA, Pili R, Zimmer-Galler IE, Janjua K, Symons RC, Campochiaro PA. Intravenous bevacizumab causes regression of choroidal neovascularization secondary to diseases other than age-related macular degeneration. Am J Ophthalmol. 2008 Feb;145(2):257-266. doi: 10.1016/j.ajo.2007.09.025. Epub 2007 Dec 11.

  PMID: 18054887 DERIVED

MeSH Terms

Conditions

Choroidal Neovascularization; Myopia, Degenerative

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myopia; Refractive Errors

Intervention Hierarchy (Ancestors)

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

Study Officials

• Quan D Nguyen, MD, MSc

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: June 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2008
• Last Updated: February 3, 2009

Record last verified: 2009-01