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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Bevacizumab

Criteria

Abbreviated: Contact Coordinator or Principal investigator for expanded criteria.

Inclusion Criteria:) Subfoveal CNV in study eye due to cause other than AMD. Best corrected visual acuity of 20/30 or less in study eye. Evidence of retinal thickening or subretinal fluid by OCT in study eye. Must be fluorescein leakage due to CNV in the study eye. If the CNV is a complication of another disease (i.e. uveitis), the disease must be under stabilization for at least 3 months prior to enrollment.

(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;

1. Platelet count > 100,000 cells/mm3;

2. 9.0 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

• Exclusion Criteria:

1. Previous subfoveal thermal laser therapy.

2. Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss.

3. Significant media opacities, including cataract, which can interfere with visual acuity, assessment of toxicity, or fundus photography.

4. Any intraocular surgery in the study eye within 12 weeks of entry.

5. 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

6. 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

7. Uncontrolled hypertension defined as blood pressure consistently (at 3 or more consecutive visits) greater than 150/100 irrespective or medication.

8. Any history, physical signs, or EKG findings suggesting significant heart disease.

9. History of thromboembolism or stroke.

10. History, physical signs, or laboratory of bleeding diathesis or coagulopathy. Any history (within 3 years) of significant gastrointestinal, oral (gum), or nasal bleeding..

11. History or physical signs of peripheral vascular disease.

12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to entry.

13. Anticipation of need for major surgical procedure during the course of the study.

14. Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to entry.

15. Women who are pregnant (positive pregnancy test) or breastfeeding.

16. Protein concentration in a 24-hour urine specimen more than 1.3 x ULN.

17. History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to entry.

18. Serious, non-healing wound, ulcer, or bone fracture.

19. Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, cavitation, or history of hemoptysis.

20. Inability to comply with study and/or follow-up procedures.

21. Any patient who is on standard anticoagulant therapy [INR targeted at 2.0 to 3.0] or treatment for deep vein thrombosis, or grade 3 or 4 venous thrombosis (Table 1), is not eligible to enroll in the study. Patients who are on stable, low-dose heparin or warfarin therapy may be eligible for the study.