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Effect of Epigallocatechin-Gallate on Inner Retinal Function in Ocular Hypertension and Early Glaucoma

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ClinicalTrials.gov Identifier: NCT00476138
Recruitment Status : Unknown
Verified May 2007 by Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : May 21, 2007
Last Update Posted : May 21, 2007
Sponsor:
Information provided by:
Catholic University of the Sacred Heart

Brief Summary:
The present study attempts to evaluate the potential beneficial effects of a flavonoid, the epigallocatechingallate, on retinal ganglion cell function, evaluated by pattern electroretinogram, in subjects with ocular hypertension or early glaucoma.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: Epigallocatechin-gallate Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Supportive Care
Official Title: Functional Effects of Epigallocatechingallate on Retinal Function in Glaucoma
Study Start Date : November 2006
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources




Primary Outcome Measures :
  1. PERG [ Time Frame: six months ]

Secondary Outcome Measures :
  1. IOP [ Time Frame: six months ]
  2. Optical Coherence Tomography measurements of retinal nerve fiber layer thickness [ Time Frame: six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IOP > 21 mmHg at the time of diagnosis
  • Response to ipotensive therapy
  • No visible alterations of the optical nerve head (if OHT)
  • Visual field: normal (if OHT), < -6dB at diagnosis (if POAG)
  • Alterations in PERG
  • Familiarity for glaucoma (if OHT)

Exclusion Criteria:

  • Change of ipotensive therapy
  • Ocular surgery
  • Other ocular pathologies
  • Smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476138


Contacts
Contact: Benedetto Falsini, M.D. 01139-06-3015 ext 6344 bfalsini@rm.unicatt.it
Contact: Emilio Balestrazzi, M.D. 01139-06-3015 ext 4929 emilio.balestrazzi@rm.unicatt.it

Locations
Italy
Catholic University, Policlinico A. Gemelli (Hospital) Recruiting
Rome, Italy, 00168
Contact: Benedetto Falsini, M.D.    01139-06-3015 ext 4929    icloc@rm.unicatt.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Benedetto Falsini, MD Chatolic University of Sacred Heart, Roma
Principal Investigator: Tommaso Salgarello, M.D. Catholic University, Italy
Principal Investigator: Dario Marangoni, M.D. Catholic University, Italy

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00476138     History of Changes
Other Study ID Numbers: FISIONERVE-01
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

Keywords provided by Catholic University of the Sacred Heart:
Epigallocatechin-Gallate
Glaucoma
Optic Nerve
Pattern Electroretinogram
Retinal Ganglion Cells

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents