GlaucomaPhase 3NCT01544192
Impact of Oral Versatile Antioxidants on Glaucoma Progression
A Phase 3 study testing Gingko Biloba, α-tocopherol and Antioxidant formula in people with Glaucoma, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Gingko Biloba, α-tocopherol and Antioxidant formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2008to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received follow-up in our glaucoma polyclinics
Who cannot join
- Known ocular or systemic concomitant disorders
- Previous glaucoma surgeries
- Antioxidant usage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Şadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results
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.
Read the detailed description
A significant difference was observed between MD, PSD, s-RNFL and m-RNFL levels of groups (p<0.05) (Table 3), but when compared with Groups of Vit E and AOF, MD and s-RNFL levels of the Group GB were significantly low and PSD level was significantly high in the same group. m-RNFL level of the Vit E group was significantly higher than m-RNFL levels of GB, AOF and Control groups (p<0.05, p<0.01). In the comparison of Vitamin E with GB, MD values were found significantly higher and PSD values were significantly low (p<0.05). No statistically significant difference was present between I-RNFL levels of groups (p>0.05). While the difference between c/d levels of groups were highly significant (p<0.01) (Table 3), c/d levels of Vit E and GB groups were found significantly lower than c/d levels of AOF and Control groups (p<0.01). c/d level of the Vit E group is significantly lower than c/d levels of AOF and Control groups (p<0.01). No statistically significant difference was found between c/d levels of other groups (p>0.05).
No statistically significant difference was present between s-GCC and i-GCC levels of groups (p>0.05). A high statistically significant difference was found between m-GCC levels of groups (p<0.01). While highly 201 significant and significant difference were present between m-GCC level of the Vit E Group and m-GCC levels of AOF and Control Groups, respectively, (p<0.01, p<0.05), m-GCC level of the Group GB was significantly higher than that of Group AOF (p<0.05). No statistically significant difference was observed between m-GCC levels of other groups (p>0.05).
- Conditions
- Glaucoma
- Being tested
- Gingko Biloba, α-tocopherol, Placebo, Antioxidant formula
- Keywords
- Antioxidant, α-tocopherol, Vitamin E, Gingko Biloba, Glaucoma, Neuroprotection, Retina
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingko BilobaDrug
Also called Gingko Biloba (Vega Natural, Konya, Turkey)
2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
α-tocopherolDrug
Also called α-tocopherol (Roche Pharma, Istanbul, Turkey)
2x300 mg α-tocopherol
PlaceboDrug
control group did not receive oral neuroprotective agent
Antioxidant formulaDrug
Also called AOF (Vega Natural, Konya, Turkey)
2x1 tablet AOF
| Study group | Role | What they receive |
|---|---|---|
| retinal nerve fiber thickness | Active comparator | Not described Receives: Drug: Gingko Biloba; Drug: α-tocopherol; Drug: Placebo; Drug: Antioxidant formula |
| Mean Deviation | Active comparator | Not described Receives: Drug: Gingko Biloba; Drug: α-tocopherol; Drug: Placebo; Drug: Antioxidant formula |
| Pattern Standard Deviation | Active comparator | Not described Receives: Drug: Gingko Biloba; Drug: α-tocopherol; Drug: Placebo; Drug: Antioxidant formula |
| ganglion cell count | Active comparator | Not described Receives: Drug: Gingko Biloba; Drug: α-tocopherol; Drug: Placebo; Drug: Antioxidant formula |
| c/d ratios | Active comparator | Not described Receives: Drug: Gingko Biloba; Drug: α-tocopherol; Drug: Placebo; Drug: Antioxidant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber layer thickness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kaya N Engin, MD,PhD, Study director, Bagcilar TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544192
- Sponsor's protocol ID
- BEAH-Ophthalmol-1
- Status last verified
- Feb 2012
- First submitted
- 19 Oct 2011
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results
- ClinicalTrials.gov ID
- NCT01544192
- Acronym / sponsor ID
- BEAH-Ophthalmol-1
- Conditions
- Glaucoma
- Keywords
- Antioxidant, α-tocopherol, Vitamin E, Gingko Biloba, Glaucoma, Neuroprotection, Retina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A significant difference was observed between MD, PSD, s-RNFL and m-RNFL levels of groups (p<0.05) (Table 3), but when compared with Groups of Vit E and AOF, MD and s-RNFL levels of the Group GB were significantly low and PSD level was significantly high in the same group. m-RNFL level of the Vit E group was significantly higher than m-RNFL levels of GB, AOF and Control groups (p<0.05, p<0.01). In the comparison of Vitamin E with GB, MD values were found significantly higher and PSD values were significantly low (p<0.05). No statistically significant difference was present between I-RNFL levels of groups (p>0.05). While the difference between c/d levels of groups were highly significant (p<0.01) (Table 3), c/d levels of Vit E and GB groups were found significantly lower than c/d levels of AOF and Control groups (p<0.01). c/d level of the Vit E group is significantly lower than c/d levels of AOF and Control groups (p<0.01). No statistically significant difference was found between c/d levels of other groups (p>0.05).
No statistically significant difference was present between s-GCC and i-GCC levels of groups (p>0.05). A high statistically significant difference was found between m-GCC levels of groups (p<0.01). While highly 201 significant and significant difference were present between m-GCC level of the Vit E Group and m-GCC levels of AOF and Control Groups, respectively, (p<0.01, p<0.05), m-GCC level of the Group GB was significantly higher than that of Group AOF (p<0.05). No statistically significant difference was observed between m-GCC levels of other groups (p>0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| retinal nerve fiber thickness | Active comparator | Drug: Gingko Biloba, Drug: α-tocopherol, Drug: Placebo, Drug: Antioxidant formula |
| Mean Deviation | Active comparator | Drug: Gingko Biloba, Drug: α-tocopherol, Drug: Placebo, Drug: Antioxidant formula |
| Pattern Standard Deviation | Active comparator | Drug: Gingko Biloba, Drug: α-tocopherol, Drug: Placebo, Drug: Antioxidant formula |
| ganglion cell count | Active comparator | Drug: Gingko Biloba, Drug: α-tocopherol, Drug: Placebo, Drug: Antioxidant formula |
| c/d ratios | Active comparator | Drug: Gingko Biloba, Drug: α-tocopherol, Drug: Placebo, Drug: Antioxidant formula |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who received follow-up in our glaucoma polyclinics
Key exclusion criteria (3 listed)
- Known ocular or systemic concomitant disorders
- Previous glaucoma surgeries
- Antioxidant usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingko BilobaAlso: Gingko Biloba (Vega Natural, Konya, Turkey)2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey) | Drug | Mean Deviation, Pattern Standard Deviation, c/d ratios, ganglion cell count, retinal nerve fiber thickness |
| α-tocopherolAlso: α-tocopherol (Roche Pharma, Istanbul, Turkey)2x300 mg α-tocopherol | Drug | Mean Deviation, Pattern Standard Deviation, c/d ratios, ganglion cell count, retinal nerve fiber thickness |
| Placebocontrol group did not receive oral neuroprotective agent | Drug | Mean Deviation, Pattern Standard Deviation, c/d ratios, ganglion cell count, retinal nerve fiber thickness |
| Antioxidant formulaAlso: AOF (Vega Natural, Konya, Turkey)2x1 tablet AOF | Drug | Mean Deviation, Pattern Standard Deviation, c/d ratios, ganglion cell count, retinal nerve fiber thickness |
Primary outcome
Retinal nerve fiber layer thickness
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaya N Engin, MD,PhD study director
Bagcilar TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gingko Biloba, α-tocopherol and Antioxidant formula in people with Glaucoma, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer thickness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.