Effect of Epigallocatechin-Gallate on Inner Retinal Function in Ocular Hypertension and Early Glaucoma
Functional Effects of Epigallocatechingallate on Retinal Function in Glaucoma
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMay 21, 2007
May 1, 2007
May 18, 2007
May 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PERG
six months
Secondary Outcomes (2)
IOP
six months
Optical Coherence Tomography measurements of retinal nerve fiber layer thickness
six months
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Change of ipotensive therapy
- Ocular surgery
- Other ocular pathologies
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic University, Policlinico A. Gemelli (Hospital)
Rome, 00168, Italy
Related Publications (3)
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.
PMID: 10440253BACKGROUNDColotto 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.
PMID: 10892864BACKGROUNDFalsini B, Marangoni D, Salgarello T, Stifano G, Montrone L, Di Landro S, Guccione L, Balestrazzi E, Colotto A. Effect of epigallocatechin-gallate on inner retinal function in ocular hypertension and glaucoma: a short-term study by pattern electroretinogram. Graefes Arch Clin Exp Ophthalmol. 2009 Sep;247(9):1223-33. doi: 10.1007/s00417-009-1064-z. Epub 2009 Mar 17.
PMID: 19290537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 21, 2007
Study Start
November 1, 2006
Study Completion
July 1, 2008
Last Updated
May 21, 2007
Record last verified: 2007-05