Clinical Trials

Title: Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS) Applicator System in Patients with Diabetic Macular Ischemia

Description: Open-label, Phase 1 Study to evaluate the safety of Brimo PS DDS inserted intravitreally in patients with diabetic macular ischemia to improve visual acuity outcomes.

Coordinator (Phone Number): Mary Zajechowski, C.O.T., C.C.R.C. 248-288-9132 X-1333

Description: Lucentis monotherapy versus Lucentis + Visudyne in the treatment of naïve patients with Neovascular Age Related Macular Degeneration.

Title: A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema

Description: Comparison of the safety and efficacy of two alternate treatments for Diabetic Retinopathy.

Sponsor: University of Wisconsin-Diabetic Retinopathy Clinical Research Network.

Description: A placebo-controlled, parallel group, dose-ranging study to assess the efficacy and safety of LX211 in the treatment of active and quiescent anterior, posterior, intermediate, and pan non-infectious uveitis.

Short Title: Othera OT-551 Eye Drops to Treat Geographic Atrophy Associated with AMD

Title: A randomized, Phase II study comparing the safety and efficacy of OT-551 with placebo to treat geographic atrophy associated with age-related macular degeneration.

Coordinator (Phone Number): Mary Zajechowski, C.O.T., C.C.R.C. 248-288-9132 X-1333

Title: Evaluation of the effect of vitreous composition determined by ultrasound on ranibizumab therapy.

Description: A double masked randomized trial comparing two dose levels of ranibizumab to placebo. Laser treatment allowed in all three arms.

Description: A randomized trial to evaluate triamcinolone acetonide vs. standard care to treat macular edema assoicated with central retinal vein occlusion and branch retinal vein occlusion.

Description: A double masked randomized trial comparing three dose levels of Veg F Trap vs. Commercial Lucentis.

Short Title: Allergan AMD

Title: Protocol 206207-016 A 6-Month, Single-Masked Multicenter, Randomized, Controlled Study to assess the safety and efficacy of Dexamethasone Posterior Segment Drug Delivery System Applicator System (DEX) as Adjunctive Therapy to Lucentis compared with Lucentis Alone in the Treatment of Patients with Choroidal Neovascularization Secondary to AMD

Description: 2 Cohorts of patients-newly diagnosed or untreated and previously treated. Patients in each cohort will be randomized so that ½ of the patients receive DEX/Lucentis and ½ of the patients will receive Sham DEX/Lucentis. All patients will receive Lucentis at screening day. Patients eligible for retreatment with Lucentis at 1 month will be randomized. Third and Subsequent Lucentis injections will be based on eligibility for retreatment per monthly outcome assessments.

Sponsor: Allergan Pharmaceuticals

Sponsor Website: allergan.com

ARC Coordinator: Joanne Gondert, RN

Phone number: 248-551-0099

Principal Investigator: George Williams, M.D.

Status: Enrolling

Short Title: CATT

Title: Comparison of Lucentis and Avastin in the treatment of AMD

Description: The comparison of Age Related Macular Degeneration Treatment Trials (CATT):

Lucentis - Avastin Trial

Sponsor: National Eye Institute

Sponsor Website:

Coordinator Phone Numbers:

Lisa Staples - Royal Oak 248-288-9132 Ext. 1334

Julie Hammersley RN - Traverse City 231-938-0710

Sarita Scott - Grand Rapids 616-942-2406

Principle investigator: Michael Trese, M.D.

Status: Enrolling

Short Title: Bausch & Lomb/Diabetes

Title: An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant For At Least One Year.

Description: Anyone who has Retisert implant in x1 year is asking to come back for endothelial cell count both eyes x1. Patients will receive a stipend.

Sponsor: Bausch & Lomb

Sponsor Website: bausch.com

ARC Coordinator: Tammy Osentoski, RN

Phone number: 248-551-9866

Principal Investigator: Michael Trese, M.D.

Status: Enrolling

Short Title: Allergan Posurdex for DME 206207-012-00

Title: A 52 Week, masked, multicenter, randomized controlled trial to assess the safety and efficacy of 700 micrograms dexamethasone posterior segment drug delivery system applicator system in combination with laser photocoalation compared with laser photocoalation alone in the treatment of diffuse diabetic macular edema.

Sponsor: Allergan, Inc.

Sponsor Website: allergan.com

Coordinator (phone Number):

Traverse City - Julie Hammersley, RN - 231-938-0710

Grand Rapids - Sartia Scott - 616-942-2406

Principle Investigators: Amy Noffke, M.D. Thomas Aaberg, M.D.

Status: Enrolling

Short Title: Genentech/AMD

Title: FVF4149s Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)

Description: Patients with subretinal hemorrhage due to AMD will have surgery and injection of Lucentis. ½ patients will get a gas bubblb, and ½ patients will not get gas bubble. F/U x12 mo, where they can get monthly Lucentis injebrtionb if still needed. Total 10 patients

Sponsor: Genentech

Sponsor Website: gene.com

ARC Coordinator: Tammy Osentoski, RN

Phone number: 248-551-9866

Principal Investigator: Tarek Hassan, M.D.

Status: Enrolling

Short Title: Jerini/AMD

Title: JO642701: A Phase I Open-label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeated Doses of JSM6427 Following Administration by Intravitreal Injection in Patients with Neovascular Age-Related Macular Degeneration (AMD).

Description: The first part of this study will be a single escalating dose of JSM 6427, an antagonist whose actions are anti-angiogenesis, anti-inflammatory, and anti-fibrosis. The second part of this study, patients will receive multiple doses of the determined dose of JSM 6427. Labs and EKG’s will be done on patients.

Sponsor: Jerini Ophthalmic Inc.

Sponsor Website: jerini.com

ARC Coordinator: Tammy Osentoski, RN

Phone number: 248-551-9866

Principal Investigator: George Williams, M.D.

Status: Enrolling

Short Title: NeoVista/AMD

Title: Randomized, Prospective, Controlled Study of the NeoVista system for the treatment of Subfoveal Choroidal Neovascularization Associated with Wet AMD.

Description: Use of Beta Radiation epiretinal therapy during a surgical procedure and an injection of Lucentis, followed by an injection of Lucentis at 1 month compared with Lucentis alone given monthly x3 and then every 3 months x7. Patients will be randomized 2 Radiation/Lucentis: 1 Lucentis alone

Sponsor: NeoVista Inc.

Sponsor Website: neovistainc.com

ARC Coordinator: Joanne Gondert, RN

Phone number: 248-551-0099

Principal Investigator: Kimberly Drenser, M.D.

Status: Enrolling

Short Title: RAP Study

Title: Ranibizumab and Photodynamic Therapy in AMD

Description: Compare Ranibizumab monotherapy to reduce PDTand Ranibizumab in wet AMD

Sponsor: PI sponsored trial with drug company - Novartis

Coordinator: Joan Videtich RN - Grand Rapids - 616-942-2406

Principal Investigator: Thomas Aaberg, M.D.

Status: Enrolling

Short Title: ALCON Dry AMD

Title: An Evaluation of Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15mg or 30mg) Versus Sham Administration in Patients (Enrolled in Study “A” or Study “B”) at Risk for Developing Sight-Threatening Choroidal Neovascularization (CNV) Due to Exudative Age Related Macular Degeneration (AMD), Protocol Number C-02-60

Description: Evaluating the difference between two dosages (15 mg and 30 mg) of the investigational drug Anecortave Acetate in comparison to “sham” treatment to prevent the dry form of Macular Degeneration to progressing to wet.

Sponsor: Alcon Research, Ltd.

Sponsor Website: alconlabs.com

ARC Coordinator: Bobbie Lewis, RN

Phone number: 248-551-2883

Principal Investigator: George Williams, M.D.

Status: Follow up

Short Title: AREDS 2

Title: Age Related Eye Disease Study 2

Description: Phase III study designed to assess the effects of oral supplements of high doses of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA & EPA) for the treatment of age related macular degeneration and the development of advanced AMD.

Sponsor: National Eye Institute (NEI)

Sponsor Website: nei.gov

Principal Investigator: Alan J. Ruby M.D.

Coordinator (Phone Number):

Grand Rapids location: Debra Markus, COT - (616) 942-2406

Royal Oak location: Candice DuLong - (248) 288-9132

Traverse City location: Julie Hammersley, RN - (231) 938-0710

Status: Follow up

Short Title: VISIONCARE/AMD

Title: Protocol IMT-002: Visioncare Ophthalmic Technologies IMT (Implantable Miniature Telescope) for Patients with Central Vision Impairment Associated with Age Related Macular Degeneration or Stargardt’s Macular Dystrophy

Description: The purpose of this study is to monitor the long-term safety of the Implantable Miniature Telescope for implantation in patients with age-related macular degeneration (AMD) who participated in the Sponsor’s IMT-002 clinical trial for an additional 3 years.

Sponsor: VisionCare

Sponsor Website: visioncareinc.net

ARC Coordinator: Kristi Cumming, RN

Phone number: 248 551 4603

Principal Investigator: Michael T. Trese, M.D.

Status: Follow up

Description: To evaluate the safety of early treatment for eyes with Prethreshold ROP with eye exams for evaluation of refractive error and ocular structure at a yearly exam-2, 3,4,5,and 6 years. To evaluate the efficacy and safety of the earlier laser treatment for eyes with Prethreshold ROP with age appropriate visual acuity testing at age 4,5 years; at 6 years a masked vision exam and visual field testing will be done.

Title: A Phase II Study of Implants of Encapsulated Human NTC-201 Cells Releasing Ciliary Neurotrophic Factor (CNTF), In Participants With Visual Acuity Impairment Associated With Atrophic Macular Degeneration (Protocol CNTF-2).

Description: Evaluate the safety and effectiveness of Ciliary Neurotrophic Factor (CNTF) implants on vision in persons with Geographic Atrophy as a result of atrophic macular degeneration.

Title: A 6 Month, Phase3, Multicenter, Masked, Randomized, Sham- Controlled Trial (With 6 Month Open Label Extension) To Assess the Safety And Efficacy of 700 mg and 350 mg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System In The Treatment Of Patients With Macular Edema Following Central Retinal Vein Occlusion (CRVO) Or Branch Retinal Vein Occlusion. (BRVO).

Description: Evaluation of the safety and Efficacy of the long term treatment of retinal vein occlusions with an implant of

Title: Open-Label Treatment for Patients Completing Study B7A-MC-MBCM, Protocol B7A-MC-MBDV

Description: A continuation of a three year study to evaluate if ruboxistaurin mesylate for the treatment of moderate to severe non-proliferative diabetic retinopathy.

Title: FVF3426g: An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of ranibizumab in Subjects with Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) who have completed the Treatment Phase of a Genentech-Sponsored ranibizumab Study.

Description: Evaluating the safety and tolerability of ranibizumab when used for after the completion of a 2 year prior study, Focus, Marina, or Anchor. Additional study treatments as needed over the next 3 years.

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

Description: Treatment for DME >250microns. Treatment @ initial visit and again if needed @ 12 months or anytime thereafter. F/U x36 mo. Every 3 month visits.