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Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD

NCT ID: NCT00533689

Last Updated: 2007-09-21

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

2008 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-01-31

Brief Summary

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THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing.

This prospective, non-randomized clinical study will include patients assigned to intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as long as will be deemed necessary. Periodic electrophysiologic evaluation including Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests will be performed every 3 months.

Detailed Description

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Conditions

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Electrophysiology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Electroretinography (ERG), Visual Evoked Potentials (VEP)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of CNV secondary to AMD
* No other ocular disease
* No history of kerato-refractive surgery
* No epilepsy
* Ability to perform electrophysiologic study

Exclusion Criteria

* Pregnancy
* Minority
* Epilepsy
* History of kerato-refractive surgery
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Michaella Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Anat Loewenstein, MD

Role: STUDY_DIRECTOR

Tel-Aviv Sourasky Medical Center

Ido Perlman, PhD

Role: STUDY_CHAIR

Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel

Locations

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Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Michaella Goldstein, MD

Role: CONTACT

Phone: +972-3-6925773

Email: [email protected]

Shiri Soudry, MD

Role: CONTACT

Phone: +972-3-6925773

Email: [email protected]

Other Identifiers

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TASMC-07-MG-209-CTIL

Identifier Type: -

Identifier Source: org_study_id