Clinical Trials at Bay Area Retina Associates

Bay Area Retina Associates is proud to be involved in multiple clinical trials evaluating emerging pharmaceuticals in the treatment of a range of retinal disease. Below are trial information and criteria for several of our current studies. For further enrollment and clinical trial information, please contact our clinical trial coordinator at info@bayarearetina.com or call our Walnut Creek office at (925) 943-6800.

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Disease: Laser Photocoagulation for Diabetic Macular Edema

Study Sponsor: U.S. Department of Health and Human Services National Institutes of Health. More details regarding this trial can be found at the NIH website.

Study Design: Phase III trial to compare the effect of two different laser techniques on retinal thickness, either argon green or yellow. Both techniques involve identical grid treatment. Patients will be followed approximately every four months for three years, with safety visits conducted after each treatment visit.

Enrollment: Starting approximately mid May 2004

Inclusion Criteria:

• Male or Female > 18 years of age
• Center involved macular edema secondary to either BRVO or CRVO documented for at least three months but not longer than 18 months
• ETDRS VA between 20/40 and 20/200 in the study eye and < 20/400 in the non-study eye
• Retinal thickness > 250 microns on the central subfield of the OCT topographic map formed by six radial scans

Exclusion Criteria:

• History of focal or grid laser in the study eye
• Intravitreal steroid in either eye
• History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within four months of randomization or topical/inhaled steroids in current use more than two times per week.
• Evidence of vitreomacular traction or epiretinal membrane, either on clinical exam or OCT thought to be contributing to macular edema.
• Glaucoma in either eye
• Vitrectomy in the study eye

If you have a patient that may meet these criteria, call 1 (800) 5-RETINA (573-8462) to schedule an appointment.

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Disease: Macular Edema secondary to either Central Retinal Vein Occlusion or Branch Retina Vein Occlusion

Study Sponsor: U.S. Department of Health and Human Services National Institutes of Health. More details regarding this trial can be found at the NIH website: http://clinicaltrials.gov

Study Design: Phase III trial to compare the efficacy and safety of standard care with the efficacy and safety of intravitreal injection of triamcinolone. Patients will be followed approximately every four months for three years, with safety visits conducted after each treatment visit. Eligible participants within each of these two disease entities will be randomized in a 1:1:1 ratio to one of three groups:

1. Standard care group Æ grid laser photocoagulation
2. Intravitreal injection of 4mg of triamcinolone acetonide
3. Intravitreal injection of 1mg of triamcinolone acetonide

Enrollment: Starting approximately mid May 2004

Inclusion Criteria:

• Male or Female > 18 years of age
• Center involved macular edema secondary to either BRVO or CRVO documented for at least three months but not longer than 18 months
• ETDRS VA between 20/40 and 20/200 in the study eye and < 20/400 in the non-study eye
• Retinal thickness > 250 microns on the central subfield of the OCT topographic map formed by six radial scans

Exclusion Criteria:

• History of focal or grid laser in the study eye
• Intravitreal steroid in either eye
• History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within four months of randomization or topical/inhaled steroids in current use more than two times per week.
• Evidence of vitreomacular traction or epiretinal membrane, either on clinical exam or OCT thought to be contributing to macular edema.
• Glaucoma in either eye
• Vitrectomy in the study eye

If you have a patient that may meet these criteria, call 1 (800) 5-RETINA (573-8462) to schedule an appointment. Please indicate the clinical trial in which you are interested in having the patient evaluated. If you have more specific questions about the criteria or protocol, you may call any of our physicians or the study coordinator.

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Disease: Diabetic Macular Edema

Study Sponsor: Eli Lilly and Company

Drug: PKC Inhibitor Ruboxistaurin Mesylate (Phase III) The drug is administered by the patient orally once a day for three years. Subjects will return for study assessments every six months. Patients will have blood drawn, urinalysis, ocular examination and fundus photos taken at every study visit. A complete physical with EKG will be performed prior to randomization.

Enrollment: Enrolling 4/1/04

Inclusion Criteria:

• Male or Female > 18 years of age
• Type I or Type II diabetes mellitus
• Have diabetic macular edema greater than 500 microns and less than 3000 microns from the center of the macular as determined by the reading center
• Visual acuity 20/32 or better in the study eye

Exclusion Criteria:

• History of focal or grid laser in the study eye
• History of PRP in the study eye
• Glaucoma
• Any other non-diabetic condition that could cause or effect CME or alter visual acuity
• Vitreous or preretinal hemorrhage in the study eye
• Intravitreal steroid in the study eye in the last six months
• Vitrectomy in the study eye
• Cancer
• Renal failure

If you have a patient that may meet these criteria, call 1 (800) 5-RETINA (573-8462) to schedule an appointment. Please indicate the clinical trial in which you are interested in having the patient evaluated. If you have more specific questions about the criteria or protocol, you may call any of our physicians or the study coordinator.