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CLINICAL STUDIES AT ASSOCIATED RETINAL CONSULTANTS, PC

 OPEN FOR RECRUITMENT/ENROLLMENT

 Listed Alphabetically by Study

 

Title:  ForeseeHome

Description:  The overall objective of this two arm randomized clinical trial is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in Age-Related Eye Disease Study 2 (AREDS2) participants and non AREDS2 participants at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascular (CNV) when compared with standard of care.

Sponsor:  Notal Vision

Principal Investigator:  Alan J. Ruby, M.D.

Coordinator:  Royal Oak location:  Crystal Kinsman-(248)288-99131 x 1334

                         Grand Rapids location: Deb Markus, COT-(616)942-2406 x 1720

Status:  Enrolling


Short Title:  Santen Study

Title:  A Phase III, Multinational, Multicenter, Randomized, Double-Masked Study Assessing the Safety and Efficacy of Intravitreal Injections of DE-109 (three doses) for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye 

Sponsor: Santen, Inc                                                   

Description:  Patients with active, non-infectious Uveitis will receive a series of three intravitreal injections of study medication and will be followed for 12 months.                                                                                    

                                                                                     santen logo.gif

Sponsor Website:  www.santen.com                                                        

Principal Investigator:  Bruce Garretson, MD

Coordinators:  Tina Bell 248-288-9132 X-1315

                           Mary Zajechowski, C.O.T., C.C.R.C.  248-288-9132 X-1315 X-1333

Status:  Pending


Short Title:  RIDE Study

Title: RIDE Study for CSDME

Description: A double masked randomized trial comparing two dose levels of ranibizumab to placebo. Laser treatment allowed in all 3 arms.

Sponsor:  Genentech, Inc.

Principal Investigator:  Kimberly A. Drenser, M.D.

Coordinator Phone Number:  Tina Bell- 248-288-9132 ext. 1315

Status:  Ongoing

Sponsor Website:  gene.com


Short Title: OPH1001

Title: A phase 2, Randomized, Double-Masked, controlled trial to establish the safety and efficacy of intravitreous injections of E10030 (anti-pdgf pegylated aptamer) given in combination with Lucentis in subjects with Neovascular Age-Related Macular Degeneration

Description:  An intravitreous injection of E10030 (anti-pdgf pegylated aptamer) given in combination with Lucentis in subjects with Neovascular Age-Related Macular Degeneration

Sponsor: OPHTHOTECH CORP.

Sponsor Website: ophthotech.com

ARC Coordinator: Crystal Kinsman

Phone Number: 248-288-9132 x1334

Principal Investigator: Antonio Capone, Jr., M.D.

Status: Enrolling


 

Title:  Clinical and Genetic Analysis of Retinopathy of Prematurity

 Description:  The goal of this study is to identify clinical and genetic features of Retinopathy of Prematurity (ROP) development, and to analyze their relationships.  Participation will last approximately 6 weeks (while the infant is in the NICU), and will consist of:  A) ROP eye exam and pictures, B) ROP eye exam and pictures along with a blood or saliva specimen, or C) no eye exam, pictures or specimen.  There will be no treatment for the ROP as part of the participation in this study.   Your baby may receive treatment for their ROP while participating in this study (if deemed necessary by the MD), but it will not be part of the study.

Sponsor:  National Institute of Health, National Eye Institute

Sponsor Website: http://www.nei.nih.gov/

ARC Coordinator:  Tammy Osentoski, RN

Phone Number:  248-551-9866

Status:  Not yet recruiting


Short Title:   ThromboGenics 005

Title:  A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects with Exudative Age-Related Macular Degeneration (AMD) TG-MV-005

Description:  Ocriplasmin is the generic name for the enzyme microplasmin.  This study is to evaluate if the study drug is safe and effective in helping to assist in loosening the vitreous (gel inside the eye) from the retina in patients with wet AMD and focal vitreomacular adhesion (vitreous pulling on the retina).  Recent information demonstrates that approximately 1/3 of patients with wet AMD also have focal vitreomacular adhesions.  It is thought that the vitreomacular adhesions may cause a worsening of the wet AMD.  Subjects will receive either a single injection of Ocriplasmin (1 out of 4 chance) or a sham injection.

Sponsor:  ThromboGenics, Inc.

Sponsor Website:  www.thrombogenics.com

 ARC Coordinator:  Bobbie Lewis, RN

Phone Number:  248-551-2883

Status:  Recruiting


 

Short Title: Thrombogenics 009, Peds

Title: The MIC (Microplasmin in Children) Trial: A Randomized,Placebo-Controlled, Double-Masked,Clinical Trial of Intravitreal Microplasmin in infants and Children Scheduled for Vitrectomy (TG-MV-009)

Description: This is a 6-month study evaluating the treatment of Microplasmin injection vs. placebo in a ratio of 2:1. Microplasmin is an experimental enzyme that is being testing to see, if when given by injection into the vitreous, it will loosen the fibers that bind the vitreous and the retina.  Some eye disorders may be associated with the vitreous pulling on the retina causing traction. 

The purpose is to evaluate the safety and efficacy of an injection of Microplasmin given 30-60 minutes pre-vitrectomy(surgery) as an adjunct to conventional vitrectomy for the treatment of pediatric patients.

Sponsor:  Thrombogenics

Sponsor Website: thrombogenics.com

ARC Coordinator:  Tammy Osentoski, RN

Phone number:  248-551-9866

Principal Investigator: Antonio Capone, M.D.

Status: Recruiting


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: http://www.nei.nih.gov/

Coordinator Phone Numbers:

Mary Zajechowski, COT, CCRC - Royal Oak 248-288-9132 Ext. 1333

Julie Hammersley RN - Traverse City 231-938-0710 Ext. 1514

Deb Markus, - Grand Rapids 616-942-2406 Ext. 1720

Principle investigator: Michael Trese, M.D.

 Status:  Follow Up

 


 

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.  NV-114-03

Sponsor Website: neovistainc.com

ARC Coordinator:  Bobby Lewis, RN

Phone number:  248-551-0099

Principal Investigator: Kimberly Drenser, M.D.

Status:  Follow Up

 

 


 

 

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: Deb Markus COT - Grand Rapids - 616-942-2406 EXT 1720

Principal Investigator: Paul Raphaelain, M.D.

Status: Completed but not closed

 

 


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 EXT 1720

Royal Oak location:  Tina Bell  -  (248) 288-9132 EXT 1315

Traverse City location:  Julie Hammersley, RN  -  (231) 938-0710 EXT 1514

Status: Follow up

 


 

 Short Title: NEUROTECH Geographic Atrophy

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.

Sponsor: Neurotech USA

Sponsor Website: RenoirRetinalStudies.com

ARC Coordinator:  Bobbie Lewis, RN

Phone number: 248 –551-2883

Principal Investigator: George Williams, M.D.

Status: Extended Follow Up

 


 

*  Updated June 2011 *

 

   
 
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