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Choroidal NeovascularizationPhase 1NCT00403156

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

A Phase 1 study testing Imatinib Mesylate /Ranibizumab in people with Choroidal Neovascularization, run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 51 years and olderHealthy volunteers can take part
Conditions the study is for
Choroidal Neovascularization
What is being tested?
Imatinib Mesylate /Ranibizumab
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2006to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 51 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vitreous Retina Macula Consultants of New York, P.C.

    New York, New York, 10022

Other trials in United States

About this study

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.

Read the detailed description

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.
Being tested
Imatinib Mesylate /Ranibizumab
Keywords
Macular Degeneration
Medical subject headings
Choroidal Neovascularization, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib Mesylate /RanibizumabDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (5)

  1. Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6.

  2. Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6

  3. Change in central retinal thickness as measured by OCT at months 3 and 6 compared to baseline

  4. Proportion of subjects gaining ≥ 30 letters as measured by ETDRS visual refraction at month 3 and 6

  5. Change in leakage area seen during fluorescein angiography at 3 and 6 months as compared with baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2006 (estimated)
  2. Study startNov 2006

Why it stopped: Lack of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00403156
Sponsor's protocol ID
FVF3989S
Status last verified
Dec 2015
First submitted
22 Nov 2006
Last updated
31 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Imatinib Mesylate /Ranibizumab in people with Choroidal Neovascularization, run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00403156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.

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