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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00407719
• Date of registration: 01/12/2006
• Primary sponsor: Johns Hopkins University
• Public title: Bevicizumab (Avastin) Infusion for Choroidal Neovascularization (CNV) Not Associated With Age-Related Macular Degeneration (AMD)
• Scientific title: An Open-Label, Pilot Study of Bevacizumab in Subjects With Choroidal Neovascularization Secondary to Diseases Other Than Age-Related Macular Degeneration
• Date of first enrolment: June 2005
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00407719
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts

• Name: Quan D Nguyen, MD, MSc
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Choroidal Neovascularization

Degenerative Myopia

Pathological Myopia

Intervention(s)

Drug: Bevacizumab

Primary Outcome(s)

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. [Time Frame: each visit for study duration up to 24 mos]

Secondary Outcome(s)

CNV leakage assessed by Digital Fluorescein Angiography [Time Frame: per protocol]

Retinal thickness assessed by OCT [Time Frame: each visit]

Secondary ID(s)

05-05-16-06

FVF 3687

Source(s) of Monetary Support

Please refer to primary and secondary sponsors