Safety and Efficacy of Anti-Oxidants and Anti-inflammatory Agents in Glaucoma and Diabetic Retinopathy

This is an interventional prevention trial for Open-angle Glaucoma Read More

Inclusion Criteria:

1. Male or female of any race, at least 18 years of age.
2. Has provided verbal and written informed consent.
3. Able and willing to follow instructions, including participation in all study assessments and visits.

4. Eyes with moderate to severe primary open-angle glaucoma will be enrolled. Glaucoma severity will be graded using the WHO glaucoma staging system.

   1. OAG eyes are defined by clinical findings consistent with glaucomatous optic neuropathy (Ex: thinning, excavation, rim erosion or notching of the neuroretinal rim)
   2. Reproducible visual field defects on at least three examinations as measured by a glaucoma hemifield test (GHT) result outside normal limits and/or the presence of at least three consecutive test points on the pattern deviation plot with P<1% and at least one at P<0.05%, not including points on the edge of the field.
5. Both eyes will be enrolled.
6. Refractive error ≤5 diopters and astigmatism ≤3 diopters

Exclusion Criteria:

1. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assignment, such as age-related macular degeneration, macular dystrophy, retinopathy from systemic diseases, marked ocular media opacities that obscure retinal imaging, etc.
2. BCVA <20/200
3. Concurrent conjunctivitis, keratitis or uveitis
4. History of penetrating ocular trauma.
5. Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or anterior chamber.
6. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
7. A woman who is pregnant, nursing an infant, or planning a pregnancy

8. Has a known adverse reaction and/or sensitivity to the study drug or its compound.

   a. Including: alpha lipoic acid, citicoline, Co-enzyme Q-10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, green tea extract, and bilberry extract.

9. Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to Visit 1.
10. Is planning on having surgery at any time throughout the study duration (90 days from initiation)
11. Is currently receiving chemotherapy
12. Has a history of diabetes mellitus, seizure(s), bleeding disorder(s)
13. Has a history of uncontrolled hypertension (≥180 systolic or ≥110 diastolic on two successive measures)
14. Has a history of any radiation around the eyes
15. Currently using anticoagulant/antiplatelet drugs (patients on coumadin, clopidogral (Plavix), and plasugrel (Effient) will be excluded but that patients taking aspirin will be allowed)
16. Unwilling or unable to cease using other anti-oxidative agents or drugs.
17. Dilated pupil diameter less than 5 millimeters
18. Fluorescein drop administration within 8 hours before imaging
19. History of cataract surgery in the 3 months prior to imaging
20. History of any other intraocular surgery within 4 months prior to enrollment
21. Corticosteroid or immunosuppressive therapy within 6-months prior to imaging
22. Lens opacity ≥grade 3 on ARLNS on standard photographs (Appendix 6)
23. History of vitrectomy
24. Monocular patients