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Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy (FVF4193s)

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
The New York Eye & Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring subfoveal CNV, Wet (Exudative) AMD, macular degeneration

Eligibility Criteria

51 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Subjects of either gender, Age > 50 years
  • Best corrected visual acuity in the study eye between 20/40 and 20/320.
  • Subfoveal choroidal neovascularization, secondary to age related macular degeneration.
  • Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
  • Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography
  • Men must use barrier contraception or abstinence throughout the study.
  • Ability to return for all study visits

Exclusion Criteria:

  • Had ocular surgery within the past 60 days in the study eye.
  • Had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3 months for the study eye.
  • Has intraocular pressure ≥ 25 mmHg in the study eye.
  • Has posterior uveitis in the study eye.
  • Has ongoing infection in the study eye.
  • Has retinal or optic nerve disease that could independently affect visual acuity including high axial myopia (>-8.00 D) and diabetic retinopathy in the study eye.
  • Has anterior segment and vitreous abnormalities that would preclude adequate observation of the fundus for photographs and fluorescein angiography in the study eye.
  • Has received investigational therapy within 60 days prior to study entry.
  • Has been previously enrolled in or previous treatment with MSI-1256F for injection.
  • Has received prior approved treatment for subfoveal CNV within 60 days to study entry.
  • Has clinically uncontrolled diabetes mellitus.
  • Has other condition the investigator considers to be sound reasons for exclusion (e.g., lack of motivation, history of poor compliance, concomitant illnesses, personality disorder, mental condition, drug abuse, use of neuroleptics, physical or social condition predicting difficulty in long-term follow-up).
  • Has an allergy to sodium fluorescein dye.
  • Currently uses systemic or topical medications known to be toxic to the retina, lens, or optic nerve, such as deferoxamine, chloroquine/hydrochloroquine, tamoxifen, chlorpromazine, phenothiazines, steroids and ethambutol.
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

Sites / Locations

  • New York Eye and Ear InfirmaryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

Open Label use of Ranibizumab for wet age related macular degeneration

Outcomes

Primary Outcome Measures

Central retinal thickness
To measure the mean change in central retinal thickness as measured by OCT/ SLO and Stratus OCT from Baseline to Month 12.

Secondary Outcome Measures

change in central scotoma lesion size, density and distortion due to neovascularization
To measure the mean change in central scotoma lesion size and density as measured on OCT/ SLO microperimeter from Baseline to Month 12. To measure the mean change in the scotoma size and distortion due to neovascularization as measured on the PHP from Baseline to Month 12.

Full Information

First Posted
December 4, 2010
Last Updated
December 2, 2011
Sponsor
The New York Eye & Ear Infirmary
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01255774
Brief Title
Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy
Acronym
FVF4193s
Official Title
Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy Measured Using The Optical Coherence Tomography (OCT) Scanning Laser Ophthalmoscope (SLO) And The Foresee Preferential Hyperacuity Perimeter
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The New York Eye & Ear Infirmary
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual acuity in wet AMD, it is important to accurately measure anatomic response to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
subfoveal CNV, Wet (Exudative) AMD, macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Open Label use of Ranibizumab for wet age related macular degeneration
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
An open-label, study of intravitreally administered ranibizumab
Primary Outcome Measure Information:
Title
Central retinal thickness
Description
To measure the mean change in central retinal thickness as measured by OCT/ SLO and Stratus OCT from Baseline to Month 12.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
change in central scotoma lesion size, density and distortion due to neovascularization
Description
To measure the mean change in central scotoma lesion size and density as measured on OCT/ SLO microperimeter from Baseline to Month 12. To measure the mean change in the scotoma size and distortion due to neovascularization as measured on the PHP from Baseline to Month 12.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Subjects of either gender, Age > 50 years Best corrected visual acuity in the study eye between 20/40 and 20/320. Subfoveal choroidal neovascularization, secondary to age related macular degeneration. Any subretinal hemorrhage must comprise no more than 50% of total lesion size. Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography Men must use barrier contraception or abstinence throughout the study. Ability to return for all study visits Exclusion Criteria: Had ocular surgery within the past 60 days in the study eye. Had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3 months for the study eye. Has intraocular pressure ≥ 25 mmHg in the study eye. Has posterior uveitis in the study eye. Has ongoing infection in the study eye. Has retinal or optic nerve disease that could independently affect visual acuity including high axial myopia (>-8.00 D) and diabetic retinopathy in the study eye. Has anterior segment and vitreous abnormalities that would preclude adequate observation of the fundus for photographs and fluorescein angiography in the study eye. Has received investigational therapy within 60 days prior to study entry. Has been previously enrolled in or previous treatment with MSI-1256F for injection. Has received prior approved treatment for subfoveal CNV within 60 days to study entry. Has clinically uncontrolled diabetes mellitus. Has other condition the investigator considers to be sound reasons for exclusion (e.g., lack of motivation, history of poor compliance, concomitant illnesses, personality disorder, mental condition, drug abuse, use of neuroleptics, physical or social condition predicting difficulty in long-term follow-up). Has an allergy to sodium fluorescein dye. Currently uses systemic or topical medications known to be toxic to the retina, lens, or optic nerve, such as deferoxamine, chloroquine/hydrochloroquine, tamoxifen, chlorpromazine, phenothiazines, steroids and ethambutol. Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katy W Tai, CCRC
Phone
212-979-4251
Email
ktai@nyee.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Rosen, MD
Organizational Affiliation
New York Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy W Tai, CCRC
Phone
212-979-4251
Email
ktai@nyee.edu

12. IPD Sharing Statement

Links:
URL
http://www.nyee.edu
Description
Related Info

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Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy

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