Choroidal Neovascularization Clinical Trial
Official title:
A Phase I Study of the Inhibition of Platelet Derived Growth Factor Using Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
The purpose of study is to determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 51 Years and older |
Eligibility |
Inclusion Criteria: - Have a BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart - Have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography: - Evidence that CNV extends under the geometric center of the foveal avascular zone. - The area of the CNV must occupy at least 50% of the total lesion. - The lesion must be =4000 microns in greatest linear dimension (GLD) - For occult with no classic CNV, the lesion must have presumed recent disease progression as assessed by the Investigator and defined as having at least one of the following criteria: - Blood associated with the lesion at baseline - Loss of VA in the previous 3 months defined as either - =5 letters (ETDRS equivalent) as determined by protocol refraction and protocol measurement OR- 2 or more lines using a Snellen or equivalent chart by standard examination - =10% increase in the GLD as assessed by fluorescein angiography in the previous 3 months Exclusion Criteria: - Have a history of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye - Have atrophy under the center of the fovea - Have angioid streaks, presumed ocular histoplasmosis syndrome, myopia (greater than 6 diopters), or choroidal neovascularization secondary to other causes than AMD - Are receiving or require chronic concomitant therapy with systemic (> 5 mg) or ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for 14 or more consecutive days at any time within 6 months prior to screening - Inability to obtain photographs, fluorescein angiography, or optical coherence tomography to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access - Have received prior treatment with any anti-angiogenic compound or any investigational treatment (e.g. Macugen, Avastin [bevacizumab], Ruboxistaurin, Lucentis [ranibizumab], Retaane [anecortave acetate], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD - Have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (rip) of the retinal pigment epithelium or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion - Have any additional ocular diseases which have irreversibly compromised or follow-up could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non-proliferative diabetic retinopathy - Within two months prior to screening, have had intraocular surgery (including cataract surgery) in the study eye - Within 1 month prior to screening had YAG laser in the study eye - Have had previous intravitreal drug delivery (injection or drug device implantation) in the study eye - Have had previous pars plana vitrectomy in the study eye - Have systemic cancer under active treatment with chemotherapeutic agents - Are being treated with anti-coagulants more than 325mg of aspirin per day. - Have hepatic insufficiency as defined as an SGOT greater than the upper limit of normal or a total bilirubin 1.5 times the upper limit of normal - Have history of congestive heart failure, myocardial infarction, transient ischemic attack and/or stroke within the last 3 months. - Are using herbal products such as St.Johns Wort, acetaminophen (Tylenol), eruthromycin, or phenytoin (Dilatin) on a chronic basis |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vitreous Retina Macula Consultants of New York, P.C. | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Vitreous -Retina- Macula Consultants of New York | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in combination with a daily pill of 400mg of Imatinib Mesylate in the treatment of choroidal neovascularization secondary to age-related macular degeneration | |||
Secondary | Proportion of patients losing = 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6. | |||
Secondary | Proportion of patients gaining = 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6 | |||
Secondary | Change in central retinal thickness as measured by OCT at months 3 and 6 compared to baseline | |||
Secondary | Proportion of subjects gaining = 30 letters as measured by ETDRS visual refraction at month 3 and 6 | |||
Secondary | Change in leakage area seen during fluorescein angiography at 3 and 6 months as compared with baseline |
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