ERG/EOG Study in AMD Patients Treated With Ranibizumab

NCT ID: NCT00791427

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-09-30

Brief Summary

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This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AMD Patients

Ranibizumab

Intervention Type DRUG

0.05 ml of ranibizumab injected into the eye monthly for one year

Interventions

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Ranibizumab

0.05 ml of ranibizumab injected into the eye monthly for one year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \>55 years
* Patients to be included in the study must have AMD with choroidal neovascularization
* BCVA between 20/20 - 20/400
* Lesion size less than or equal to 12 MPS disc areas

Exclusion Criteria

* Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study
* Pregnancy (positive pregnancy test)
* 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
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* Media insufficient to obtain a view
* Other causes of CNV not related to AMD
* Active ocular or peri-ocular infection
* Ocular surgery within 1 month prior to the study
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Retina Center, Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Abdhish R. Bhavsar, M.D.

President/Physician/Owner

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Retina Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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FVF4154s

Identifier Type: -

Identifier Source: org_study_id

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