NCT00533689

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,008

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 21, 2007

Status Verified

September 1, 2007

First QC Date

September 20, 2007

Last Update Submit

September 20, 2007

Conditions

Electrophysiology

Interventions

Electroretinography (ERG), Visual Evoked Potentials (VEP)PROCEDURE

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Minority
  • Epilepsy
  • History of kerato-refractive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Interventions

Evoked Potentials, Visual

Intervention Hierarchy (Ancestors)

Evoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOcular Physiological Phenomena

Study Officials

  • Michaella Goldstein, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Anat Loewenstein, MD

    Tel-Aviv Sourasky Medical Center

    STUDY DIRECTOR

  • Ido Perlman, PhD

    Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel

    STUDY CHAIR

Central Study Contacts

Michaella Goldstein, MD

CONTACT

+972-3-6925773michgold@netvision.net.il

Shiri Soudry, MD

CONTACT

+972-3-6925773shirizayit@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 21, 2007

Study Start

January 1, 2008

Study Completion

January 1, 2010

Last Updated

September 21, 2007

Record last verified: 2007-09

Locations

IL(1)