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

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

This study is currently recruiting participants.
Verified by Catholic University of the Sacred Heart, May 2007

Sponsored by:	Catholic University of the Sacred Heart
Information provided by:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00476138

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 I Phase II

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma High Blood Pressure

ChemIDplus related topics:

Epigallocatechin gallate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Official Title:	Functional Effects of Epigallocatechingallate on Retinal Function in Glaucoma

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, Rome, Italy

Principal Investigator:	Dario Marangoni, M.D.	Catholic University, Rome, Italy

More Information

Publications:

Salgarello T, Colotto A, Falsini B, Buzzonetti L, Cesari L, Iarossi G, Scullica L. Correlation of pattern electroretinogram with optic disc cup shape in ocular hypertension. Invest Ophthalmol Vis Sci. 1999 Aug;40(9):1989-97.

Colotto A, Falsini B, Salgarello T, Iarossi G, Galan ME, Scullica L. Photopic negative response of the human ERG: losses associated with glaucomatous damage. Invest Ophthalmol Vis Sci. 2000 Jul;41(8):2205-11.

Study ID Numbers:	FISIONERVE-01
First Received:	May 18, 2007
Last Updated:	May 18, 2007
ClinicalTrials.gov Identifier:	NCT00476138
Health Authority:	Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:

Epigallocatechin-Gallate

Glaucoma

Optic Nerve

Pattern Electroretinogram

Retinal Ganglion Cells

Study placed in the following topic categories:

Epigallocatechin gallate

Ganglion Cysts

Glaucoma

Eye Diseases

Glaucoma, Open-Angle

Vascular Diseases

Hypertension

Ocular Hypertension

Additional relevant MeSH terms:

Anticarcinogenic Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antimutagenic Agents

Cardiovascular Diseases

Central Nervous System Agents

Neuroprotective Agents

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008