Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy

NCT01255774 | Unknown Phase 3

• 1 other identifier: NYEE-07.14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

subfoveal CNV; Wet (Exudative) AMD; macular degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• change in central scotoma lesion size, density and distortion due to neovascularization

  12 months

Study Arms (1)

Ranibizumab

EXPERIMENTAL

Open Label use of Ranibizumab for wet age related macular degeneration

Drug: ranibizumab

Interventions

ranibizumab DRUG

An open-label, study of intravitreally administered ranibizumab

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 51 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead
• Genentech, Inc.: collaborator

Study Sites (1)

New York Eye and Ear Infirmary

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Richard B Rosen, MD

  New York Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katy W Tai, CCRC

CONTACT

212-979-4251; ktai@nyee.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2010
• First Posted: December 7, 2010
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2011

Record last verified: 2011-12

Locations

US (1)