Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of study is to determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vitreous -Retina- Macula Consultants of New York
• Collaborator: Genentech, Inc.
• Treatments: Imatinib Mesylate; Ranibizumab

Criteria

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