Overview

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Withdrawn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