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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by The New York Eye & Ear Infirmary.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01255774
First received: December 4, 2010
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: ranibizumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • Central retinal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 20
Study Start Date: June 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
Open Label use of Ranibizumab for wet age related macular degeneration
Drug: ranibizumab
An open-label, study of intravitreally administered ranibizumab
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   51 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255774

Contacts
Contact: Katy W Tai, CCRC 212-979-4251 ktai@nyee.edu

Locations
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Katy W Tai, CCRC    212-979-4251    ktai@nyee.edu   
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Genentech
Investigators
Principal Investigator: Richard B Rosen, MD New York Eye and Ear Infirmary
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Rosen, MD, Vice Chairman of Dept of Ophthalmology and Director of Research, New York Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01255774     History of Changes
Other Study ID Numbers: NYEE-07.14
Study First Received: December 4, 2010
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The New York Eye & Ear Infirmary:
subfoveal CNV
Wet (Exudative) AMD
macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014