"Memantine Study" from Glaucoma Associates of Texas

Glaucoma Patient Studies

STUDY: Memantine Study

PRIMARY INVESTIGATOR: Dr. Fellman

PURPOSE OF STUDY:

The purpose of this study is to investigate the safety and effectiveness of oral memantine (supplied in tablets, to be taken by mouth) in the treatment of certain types of chronic glaucoma. Approximately 1,050 subjects will participate in this study at approximately 50 study centers worldwide.

You will be assigned to receive one of three treatments in this study: treatment with 20mg of oral memantine each day, treatment with 10mg of oral memantine each day, or treatment with placebo (the study agent without the active ingredient). There is approximately a 29% chance that you will be assigned to receive placebo. Neither you nor the study doctor will know which medication you are given, but in the event of an emergency, that information can be obtained.

Oral memantine has been sold in Europe for treatment of dementia syndrome and spastic disorders such as Parkinson’s disease, but is not marketed in any country for use in glaucoma. That is why it is being investigated in this study. Oral memantine has been studied by Allergan in 82 subjects with ocular hypertension or open-angle glaucoma.

DURATION OF SUBJECT PARTICIPATION:

There will be a total of 20 study visits over a period of approximately 48 months.

INCLUSION CRITERIA:

To be considered for enrollment into the study you must:

Be of the legal age consent (18 years, in the US)- 80 years of age

Give written informed consent

Have chronic open-angle glaucoma in both eyes (the study doctor will determine whether you have open-angle glaucoma)

Have vision of 20/32 or better (with glasses if necessary)

Understand the study instructions, and be able to follow the study instructions.

EXCLUSION CRITERIA:

You will not be able to participate in the study if you are a woman who is pregnant, nursing, or planning a pregnancy or if you are a woman of childbearing potential, not using a reliable means of contraception. If you are pregnant, nursing, or planning a pregnancy, please notify the study doctor immediately.

You will not be able to participate in the study if any of the following apply:

History of epilepsy or psychiatric disease

Kidney problems

Eye surgery within the last three months

Recent dizziness (within 1 week before the study)

COMPENSATION:

You will be compensated for your time and inconvenience you may experience while participating in this study. You will receive:

$100 per visit for the five long visits (Screening, Months 12,24,36, and 48)

$50 per visit for the five medium length visits (Baseline and Months 6,18,30, and 42), and

$25 per visit for the 10 short visits (Day 21, Day 49 and Months 3,9,15,21,27,33,39 and 45)

If you complete the entire study, you will receive $1000.00. If you withdraw for unforeseen personal reasons or circumstances preventing further participation, you will receive a prorated payment for each scheduled visit made to the clinic. Other studies are forthcoming in pediatric glaucoma ranging from birth to six years of age.

If you are interested in learning more about one of our Glaucoma Studies, please call Michelle Cochran at 214-360-0000 ext. 126 or email her at mcochran@medsynergies.com.

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Glaucoma Associates of Texas
10740 N. Central Expressway, Suite 300
Dallas, TX 75231
Office: 214-360-0000
Fax: 214-360-0083