What is a clinical trial?

It is a study to evaluate the effectiveness and safety of an experimental medication or an experimental medical device by monitoring their effects on large groups of people.

After testing new therapies or procedures in the laboratory and in animal studies, the experimental treatments or devices with the most promising laboratory results are moved into clinical trials. Clinical trials (also called clinical research) may be conducted by government health agencies such as NIH, researchers affiliated with a hospital or university medical program, independent researchers, or private industry. Ideas for clinical trials come from researchers or physicians.

All participants are volunteers. Participants are generally divided into two or more groups, including a control group that does not receive the experimental treatment, receives a placebo (inactive substance) instead, or receives a tried-and-true therapy for comparison purposes.

Government agencies approve or disapprove new treatments based on clinical trial results. While important and highly effective in preventing obviously harmful treatments from coming to market, clinical trials are not always perfect in discovering all side effects, particularly effects associated with long-term use and interactions between experimental drugs and other medications.

For some patients, clinical trials represent an avenue for receiving promising new therapies that would not otherwise be available. Patients with difficult to treat illness’ or currently "incurable" diseases, may want to pursue participation in clinical trials if standard therapies are not effective.

The Jones Eye Institute is now enrolling for the following clinical trials (studies):

Macular Edema following Central Retinal Vein Occlusion (CRVO)or Branch Retinal Vein Occlusion (BRVO)

Title: A Six-Month, Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial (with Six-Month Open- Label Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Macular Edema Following Central Retinal Vein Occlusion or Branch Retinal Vein Occlusion

Sponsor:        Allergan Inc.          Protocol #206207-008
PI:                  Ammar Safar, M.D.
Phase:            III  
Purpose:        The purpose of this study is to investigate the safety of Dexamethasone Drug Delivery System in the treatment of macular edema due to central retinal vein occlusion or branch retinal vein occlusion. We are testing two different doses of dexamethasone using an investigational applicator to inject the drug to the back of the eye.

Main Criteria For Who Can Participate:

• Macular Edema in the study eye due to BRVO or CRVO
• Duration of macular edema 6 weeks to 12 months (BRVO) or 6 weeks to 9 months (CRVO) prior to first visit
• Patients at least 18 years of age.
• Best-corrected visual acuity of 20/50 to 20/200 in study eye and at least 20/200 in the non-study eye

 Main Criteria For Who Can NOT Participate:

• Patients who have had a previous steroid injection in the study eye
• Patients who have glaucoma or high eye pressure in either eye
• Patients who are pregnant, or plan to become pregnant
• Any ocular surgery in the study eye within 90 days of the first visit
• Patients who have been in another drug or device study with 30 days prior to the first visit

Treatment:      You have to be at least 18 years old to participate.  You will return for 14 visits to your study                
                         doctor’s office over a course of 12 months so your eye condition can be monitored.
Contact:          Deborah Troillett, e-mail:  troillettdeborahl@uams.edu
                         Phone:  (501) 526-6394
                         or
                         Shirley Hankins, e-mail:  hankinsshirleyk@uams.edu
                         Phone:  (501) 296-1156

Diabetic Macular Edema Study

Title: A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 µg/day and ASI-001B 0.2 µg/day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects with Diabetic Macular Edema

Sponsor:        Alimera Sciences     Protocol # C-01-05-001
PI:                  Ammar Safar, M.D.
Phase:            III  
Purpose:         The purpose of this study is to look at a drug called Fluocinolone acetonide.  It is injected into the eye using a new drug delivery system.  The study medicine is slowly release over a very long time (more than a year and possibly up to 3 years).  Fluocinolone acetonide is one of many drugs which is called corticosteroids or glucocorticcoids.  Its action is to reduce the build-up of fluid, known as edema.

Main Criteria For Who Can Participate:

• Diabetic patients who are currently taking medicine for their diabetes
• Patients diagnosed with Diabetic Macular Edema
• Patients at least 18 years of age.
• Best-corrected visual acuity of 20/50 to 20/400 in study eye and no worse than 20/400 in the non-study eye
• At least one macular laser treatment more than 12 weeks prior to the first visit

 Main Criteria For Who Can NOT Participate:

• Patients who have been in another drug study in the last 3 months
• Patients who have glaucoma or high eye pressure
• Patients who have received treatments in the study eye other than laser, in the past 3 months
• Patients who are pregnant, or plan to become pregnant
• Any ocular surgery in the study eye within 12 weeks of the first visit

Treatment:      You have to be at least 18 years old to participate.  You will return for 18 visits to your study doctor’s office over a course of 3 years so that your eye condition can be monitored.
Contact:          Shirley Hankins, e-mail:  hankinsshirleyk@uams.edu
                         Phone:  (501) 296-1156
                         or
                         Deborah Troillett, e-mail:  troillettdeborahl@uams.edu
                         Phone:  (501) 526-6394

Age-Related Macular Degeneration  

Title: Age-Related Eye Disease Study 2 (AREDS2): A Multi-center Randomized
                      Trial of Lutein, Zeaxanthin, and Omega-3 Long-Chain Polyunsaturated   
                       Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid
                       [EPA]) in Age-Related Macular Degeneration

Sponsor:        National Eye Institute     Protocol # AREDS2
PI:                  Ammar Safar, M.D.
Phase:            II  
Purpose:         The purpose of this study is to see whether certain vitamins can help to prevent or slow macular degeneration.

Main Criteria For Who Can Participate:

• Willingness to take at least three nutritional supplement pills daily for at least five years
• Willingness to under go examinations at yearly intervals for at least five years
• Patients have to be from 50 to 85 years of age
• Patients diagnosed with Age-Related Macular Degeneration
• Large drusen in study eye (Drusens are yellow spots found in the back of the eye, seen only by your eye doctor.)

 Main Criteria For Who Can NOT Participate:

• Ocular disease in either eye other than Age-Related Macular Degeneration
• Previous retinal or other ocular surgical procedures that may future complicate the assessment of the progression of Age-Related Macular Degeneration
• History of Lung Cancer
• Any major disease that might make follow-up difficult in the next 5 years

Treatment:      You will return for 8 visits to your study doctor’s office over a course of   6 years so that your eye condition can be monitored.
Contact:          Deborah Troillett, e-mail:  troillettdeborahl@uams.edu
                         Phone:  (501) 526-6394
                         or
                         Shirley Hankins, e-mail:  hankinsshirleyk@uams.edu
                         Phone:  (501) 296-1156