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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00476138
First received: May 18, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
 Drug: Epigallocatechin-gallate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Functional Effects of Epigallocatechingallate on Retinal Function in Glaucoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • PERG [ Time Frame: six months ]

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

Estimated Enrollment: 40
Study Start Date: November 2006
Estimated Study Completion Date: July 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Additional 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
Study First Received: May 18, 2007
Last Updated: May 18, 2007
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013