NCT01544192

Brief Summary

Background: The significance of retinal ganglion cell protection in the glaucoma led the view that, glaucomatous optical neuropathy can also be considered as a pathology of central nervous system. It is known that α-tocopherol and Gingko Biloba have specific neuroprotective and vasoregulatory activities, in addition to antioxidant effects. In this study, the investigators compared early neuroprotective effects of α-tocopherol and GB with each other as well as control and a strong antioxidant formulation in patients with glaucoma. Methods: In this non-randomized control trial, 120 eyes of 60 patients with glaucoma were enrolled into the study and divided into 4 groups, each consisting of 30 eyes. Unlike the controls, patients in the 3 antioxidant groups received α-tocopherol, Gingko Biloba and a strong antioxidant formula for 3 months. Central vision field and MD, PSD and OCT as well as thickness of retinal nerve fiber layer, ganglion cell counts and c/d ratios were recorded. The data were compared statistically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
Last Updated

March 5, 2012

Status Verified

February 1, 2012

Enrollment Period

1.6 years

First QC Date

October 19, 2011

Last Update Submit

March 2, 2012

Conditions

Glaucoma

Keywords

Antioxidantα-tocopherolVitamin EGingko BilobaGlaucomaNeuroprotectionRetina

Outcome Measures

Primary Outcomes (1)

  • Retinal nerve fiber layer thickness

    3 months

Study Arms (5)

retinal nerve fiber thickness

ACTIVE COMPARATOR
Drug: Gingko BilobaDrug: α-tocopherolDrug: PlaceboDrug: Antioxidant formula

Mean Deviation

ACTIVE COMPARATOR
Drug: Gingko BilobaDrug: α-tocopherolDrug: PlaceboDrug: Antioxidant formula

Pattern Standard Deviation

ACTIVE COMPARATOR
Drug: Gingko BilobaDrug: α-tocopherolDrug: PlaceboDrug: Antioxidant formula

ganglion cell count

ACTIVE COMPARATOR
Drug: Gingko BilobaDrug: α-tocopherolDrug: PlaceboDrug: Antioxidant formula

c/d ratios

ACTIVE COMPARATOR
Drug: Gingko BilobaDrug: α-tocopherolDrug: PlaceboDrug: Antioxidant formula

Interventions

Gingko BilobaDRUG

2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)

Also known as: Gingko Biloba (Vega Natural, Konya, Turkey)
Mean DeviationPattern Standard Deviationc/d ratiosganglion cell countretinal nerve fiber thickness
α-tocopherolDRUG

2x300 mg α-tocopherol

Also known as: α-tocopherol (Roche Pharma, Istanbul, Turkey)
Mean DeviationPattern Standard Deviationc/d ratiosganglion cell countretinal nerve fiber thickness
PlaceboDRUG

control group did not receive oral neuroprotective agent

Mean DeviationPattern Standard Deviationc/d ratiosganglion cell countretinal nerve fiber thickness
Antioxidant formulaDRUG

2x1 tablet AOF

Also known as: AOF (Vega Natural, Konya, Turkey)
Mean DeviationPattern Standard Deviationc/d ratiosganglion cell countretinal nerve fiber thickness

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who received follow-up in our glaucoma polyclinics

You may not qualify if:

  • Known ocular or systemic concomitant disorders
  • Previous glaucoma surgeries
  • Antioxidant usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Şadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Ginkgo Extractalpha-Tocopherol

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesTocopherolsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kaya N Engin, MD,PhD

    Bagcilar TRH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

March 5, 2012

Study Start

April 1, 2008

Primary Completion

November 1, 2009

Study Completion

February 1, 2012

Last Updated

March 5, 2012

Record last verified: 2012-02

Locations

TU(1)