Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
This study has been withdrawn prior to enrollment.
(Lack of recruitment)
Information provided by:
Vitreous -Retina- Macula Consultants of New York
First received: November 22, 2006
Last updated: November 6, 2008
Last verified: November 2008
The purpose of study is to determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization.
Drug: Imatinib Mesylate /Ranibizumab
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 Outcome Measures:
- Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6.
- Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6
- Change in central retinal thickness as measured by OCT at months 3 and 6 compared to baseline
- Proportion of subjects gaining ≥ 30 letters as measured by ETDRS visual refraction at month 3 and 6
- Change in leakage area seen during fluorescein angiography at 3 and 6 months as compared with baseline
| Estimated Enrollment:
| Study Start Date:
This is an open-label dose escalating study (n=15) to evaluate the safety and tolerability of the addition of imatinib mesylate to the Lucentis treatment regime over a 6 month period in patients with newly diagnosed choroidal neovascularization:
- 5 patients will be treated with 4 weeks of imatinib mesylate 400mg per day (the lowest typical starting dose) to be started concurrently with ranibizumab (Lucentis) 0.5mg intravitreal injection. The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis.
- If imatinib mesylate is safely tolerated for the first 4 weeks, the following set of 5 patients will be treated with 6 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 0.5mg intravitreal injection. The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis.
- If imatinib mesylate is safely tolerated for the first 6 weeks, the following set of 5 patients will be treated with 8 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 0.5mg intravitreal injection. The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis.
|Ages Eligible for Study:
||51 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403156
|Vitreous Retina Macula Consultants of New York, P.C.
|New York, New York, United States, 10022 |
Vitreous -Retina- Macula Consultants of New York
||Richard F. Spaide, M.D.
||Vitreous Retina Macula Consultants of New York, P.C.
No publications provided
||Richard Spaide, MD, Vitreous Retina Macula Consultants of New York
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 22, 2006
||November 6, 2008
||United States: Food and Drug Administration
Keywords provided by Vitreous -Retina- Macula Consultants of New York:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 03, 2015
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors