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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: Thrombogenics
006, Trust
Title: A Randomized, Placebo Controlled,
Double-Masked, Multicenter Trial Of Microplasmin Intravitreal Injection For
Non-Surgical Treatment Of Focal Vitreomacular Adhesion, Phase III
Description:
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 usual option for treatment of these
disorders is an eye surgery called vitrectomy. What this study is evaluating is
to see if the Microplasmin will break the fibers and therefore resolving the
traction. This is a 6-month study evaluating the treatment of Microplasmin
injection vs. placebo in a ratio of 3:1.
Sponsor: Thrombogenics
Sponsor Website:
thrombogenics.com
ARC Coordinator: Tammy
Osentoski, RN
phone number: 248-551-9866
Principal Investigator:
Kimberly Drenser, M.D.
Status: Completed
Short Title: Block Rop
Title: PAN-VEGF Blockade for
the Treatment of ROP
Description: Safety/drug
tolerance using complete VEGF blockage in infants with aggressive posterior ROP
(zone 1 ROP requiring treatment per ETROP standards)in order to decrease the
abnormal vascular activity after conventional laser ablation with improved or
favorable structural outcome.
Avastin 0.75mg/0.03cc will be given as a one time intravitreal injection and
a blood sample will be obtained.
Infants will be followed for weekly until they reach a PMA of 44 weeks with
Retcam fundus photography.
Sponsor: Investigator sponsored
Sponsor Website: Vision Research Foundation
ARC Coordinator: Tammy Osentoski, RN
Phone number: 248-551-9866
Principal Investigator: Kimberly Drenser, MD, PhD
Status: Closed
Short
Title: Brimonidine Study
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.
Sponsor: Allergan
Sponsor website:
allergan.com
Principal Investigator: George A. Williams, M.D.
Coordinator (Phone Number): Mary Zajechowski, C.O.T., C.C.R.C.
248-288-9132 X-1333
Status: Enrolling
Short
Title: DENALI Study
Title: DENALI Study
Description: Lucentis monotherapy versus Lucentis + Visudyne in
the treatment of naïve patients with Neovascular Age Related Macular
Degeneration.
Sponsor: Novartis
Sponsor Website: novartis.com
Principal Investigator: Amy Noffke, M.D.; George A. Williams,
M.D.
Coordinator (Phone Number):
Royal Oak: Lisa Staples -
248-288-9132
Traverse City: Julie
Hammersley, RN - 231-938-0710
Status: Enrolling
Short
Title: INTRAVIT/LASER STUDY for DME
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.
Sponsor website:
public.drcr.net
Principal Investigator: Michael T. Trese, M.D.
Coordinator (Phone Number):
Grand Rapids: Contact:
Joan Videtich,R.N. - 616-942-2406
Royal Oak: Contact: Mary
Zajechowski, COT - 248-288-9132, EXT. 1333
Status: Enrolling
Short
Title: Luminate Study
Title: Dose-ranging/Placebo-controlled Trial of LX211 for
Uveitis
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.
Sponsor: Lux Biosciences, Inc.
Sponsor Website:
luxbio.com
Principal Investigator: Dr. Thomas Aaberg, Jr.
Coordinator (Phone Number): Joan Videtich, RN - (616) 942-2406
Status: Closed to Enrollment
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.
Description: Comparison of the safety and efficacy of:
l
0.45% OT-551 ophthalmic solution
l
0.3% OT-551 ophthalmic solution
l
0.0% OT-551 ophthalmic solution (vehicle placebo)
Sponsor: Othera Pharmaceuticals
Sponsor Website:
othera.com
Principal Investigator: Tarek S. Hassan, M.D.
Coordinator (Phone Number): Mary Zajechowski, C.O.T., C.C.R.C.
248-288-9132 X-1333
Status: Enrolling
Short
Title: PVD Study
Title: Evaluation of the effect of vitreous composition
determined by ultrasound on ranibizumab therapy.
Sponsor: Vision Research Foundation
Sponsor website:
visionrf.org
Principal Investigator: Michael T. Trese, M.D.
Coordinators: Candice DuLong - Royal Oak
248-288-9132 ext. 1315
Julie Hammersley,RN - Traverse City 231-938-0710
Joan
Videtich, R.N. -
Grand Rapids 616-942-2406
Status: Enrolling
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 three
arms.
Sponsor: Genentech, Inc
Sponsor Website:
gene.com
Principal Investigator:
Kimberly A. Drenser, M.D., Ph.D.
Coordinator (Phone Number): Lisa M Staples - 248-288-9132 ext.
1334
Status: Enrolling
Short
Title: SCORE Study
Title: The Standard Care vs. Corticosteroid for Retinal Vein
Occlusion Study
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.
Sponsor: Emmes Coorporation
Sponsor website:spitfire.emmes.com
Principal Investigator: Alan J. Ruby, M.D.
Coordinator (Phone Number): Candice DuLong - Royal Oak
248-288-9132 ext. 1315
Status: Enrolling
Short
Title: VIEW 1 Study
Title: VIEW 1 study for Wet AMD
Description: A double masked randomized trial comparing three
dose levels of Veg F Trap vs. Commercial Lucentis.
Sponsor: Regeneron/PPD inc.
Sponsor Website:
ppd.com
Principal Investigator:
Tarek S. Hassan, M.D.
Coordinator (Phone Number): Lisa M Staples - 248-288-9132 ext.
1334
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
Deb Markus, R.N. - 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: Completed
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
-
Deb Markus, R.N.
- 616-942-2406
Principle
Investigators: Amy Noffke, 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: Bobby Lewis, RN
Phone
number: 248-551-0099
Principal Investigator: Kimberly Drenser, M.D.
Status: Follow Up
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