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[IP] Clinical Trial
If anyone is interested please reply to "Market Research" <email @ redacted>
Market Research wrote:
> PATIENT RECRUITMENT INVITATION
> Volunteers Needed
> Volunteers are needed for a clinical research trial of an investigational
> drug that is being tested as a possible treatment for people with diabetes
> and diabetic eye disease. The goal of this study is to determine if the
> investigational drug can prevent the progression of diabetic eye disease.
> Based on the information you have provided Sapient Health Network, you may
> be a qualified candidate for this clinical trial.
> Why Get Involved?
> By taking part in this study, you will be directly helping to answer
> important questions that could improve the long-term health of millions of
> people with diabetes worldwide.
> Diabetic retinopathy is a major cause of blindness in industrialized
> nations. It is the leading cause of blindness in Americans between the ages
> of 20 and 74 years and accounts for 12% or 8000 of the new cases of
> blindness each year in the United States. Ninety percent of patients with
> diabetes will develop some degree of retinopathy over their lifetime. A
> majority of the visual loss suffered by patients with diabetes can be
> attributed to diabetic macular edema and proliferative diabetic retinopathy.
> If You Take Part In This Study, You Will Receive:
> · Lab tests and clinic visits as required for the study at no cost.
> · Physical and eye exams as required for the study at no cost.
> What Happens During the Trial?
> If you participate in this study, you will visit an eye doctor to have a
> routine eye examination that will also include fundus photography (pictures
> taken of the back of your eyes). You will also have blood and urine tests.
> You will have a physical exam and a medical history taken by a medical
> doctor and an electrocardiogram to monitor your heart and its rhythm. You
> will complete a questionnaire on your ability to see. If these evaluations
> indicate that you can participate in the study, you will receive your
> tablets with instructions to take two (2) tablets by mouth once a day for a
> minimum of twelve (12) months and up to a maximum of thirty-six (36)t
> months. You will be assigned to one of four treatments, including the
> investigational drug at a low, medium or high dose or a placebo. Which
> treatment you receive will be determined by a chance process (like flipping
> a coin). The probability that you will receive any one of the treatments is
> 1 in 4. Neither you nor your doctor will know which treatment group you are
> assigned to.
> You will return to the doctor's office approximately 1 month after starting
> the treatment and then at 3-month intervals until you have completed at
> least twelve (12) and up to thirty-six (36)t months of the study. At certain
> clinic visits, you will have visual acuity measured and fill a questionnaire
> on your ability to see. Blood and urine tests and electrocardiograms will be
> done at certain visits. You will be examined by the eye doctor (5 to 9
> times) and the medical doctor (2 to 4 times). You will have fundus
> photography done approximately 5 to 9 times.
> The study is called a "double-mask study" because neither the doctor nor the
> person in the study will know who is receiving drug and who is receiving
> placebo. This is done to ensure fair judgment of the treatment groups.
> Study Participant Qualifications:
> To be enrolled in this study, you must be age 18 or older, have type 1 or
> type 2 diabetes, and have either leakage of fluid or moderate to severe
> diabetic eye disease in one or both eyes. In addition, your hemoglobin A1c
> must be less than or equal to 13.0%, and you must meet other eligibility
> criteria. Patients may be male or female. If you are a female of
> childbearing potential, you must be willing to use a medically accepted
> means of contraception during the study (that is, intrauterine device, oral
> contraceptive, implant, Depo-Provera, or barrier devices).
> There are also additional exclusions due to current medications and medical
> conditions. Your specific medical situation will be reviewed with you in
> detail to determine final qualification for this study.
> (Authentication marker --
> ~3%e%1LYDMRT_0_ZHkzyo1g%33%1%5846%wwLNIQ_v%34721& -- do not remove.)
> If you are interested, please reply to this email as soon as possible and we
> will provide you with the name, address, and phone number of a clinical
> study site in your area.
> To respond to this survey, create a reply e-mail message that contains the
> survey. Some e-mail systems require you to manually copy and paste the
> survey into your reply. Make sure the reply contains the survey
> authentication marker.
> To answer a question, type between the brackets like this: [ your
> response ]. Please make no other changes to this survey.
> 1. First Name or Initial [ ]
> 2. Last Name or Initial [ ]
> 3. Zip Code [ ]
> 4. Date of Birth [ ]
> Thank you for considering this study.
Insulin-Pumpers website http://www.insulin-pumpers.org/