A Phase 1 interventional study of Bevacizumab in Choroidal Neovascularization, Degenerative Myopia and Pathological Myopia, sponsored by Johns Hopkins University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-02-03.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
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.
Bevacizumab is a recombinant humanized monoclonal antibody against VEGF. It has been approved by the FDA for the treatment of metastatic colon cancer 18. We hypothesize that VEGF also plays a role in the development of CNV in pathologic myopia. Therefore, employing a mode of therapy that would decrease the risks posed to eyes with attenuated sclera, we have treated, through special approval by the Pharmacy and Therapeutic Committee of the Johns Hopkins University School of Medicine, two patients with persistent myopic CNV with intravenous bevacizumab 19. Despite multiple treatments with PDT, the CNV remained active and vision continued to decline in these two index patients. After four infusions of bevacizumab, the CNV became inactive. Six months after the last infusion in each patient, the CNV showed no evidence of activity or leakage on fluorescein angiography. Vision also improved in the diseased eyes of both patients. The two patients tolerated the infusions well, with no adverse events detected. In particular, blood pressure remained stable and no proteinuria was noted on serial analyses of 24-hour urine collections. The Bascom Palmer Eye Institute at the University of Miami has also recently reported favorable outcomes of bevacizumab administered in repeated doses to 14 patients (age > 65 years) with CNV secondary to AMD that has been refractory to other therapies.
We propose a non-randomized, open-label pilot study to evaluate the effect of bevacizumab in patients with CNV due to any cause other than AMD. This design will allow us to closely monitor safety and tolerability of bevacizumab while we evaluate 3 bioactivity outcomes. Based upon dramatic responses in two patients with CNV due to myopic degeneration, we hypothesize that treatment with bevacizumab may have major advantages over current standard of care.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 10 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
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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;
Patients must be able to return for all study visits within required visit windows.
Patients must provide written informed consent
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
Retinal thickness assessed by OCT
Time frame: each visit
CNV leakage assessed by Digital Fluorescein Angiography
Time frame: per protocol
No study locations are listed for this record.
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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