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Ophthalmic Surgery Trials

A Phase 2/3, randomized, double-masked, sham-controlled trial of QPI-1007 delivered by single or multi-dose intravitreal injection(s) to subjects with acute nonarteritic anterior ischemic optic neuropathy (NAION)

Aims:  There is currently no approved treatment for NAION. Participants in this study will be assigned to receive an injection of an investigational drug or sham procedure to one eye over a four-month treatment period. The drug is being studied to determine its ability to treat vision loss that can occur in NAION.

Diagnosis:  Non-arteritic anterior ischemic optic neuropathy (NAION)

Principal Investigator: John Pula, MD

IRB Approval Number: EH16-164

Sponsor:  Quark Pharmaceuticals, Inc.

Contact:  Interested patients may contact Mira Shiloach at 847.657.1750, mshiloach@northshore.org

Open to Enrollment:  Yes

 

Zoster Eye Disease Study (ZEDS): A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment.

Aims: This is a multi-center randomized clinical trial to look at whether long-term treatment with Valacyclovir versus placebo will be effective in decreasing eye disease and/or severe pain in patients with herpes zoster ophthalmicus

Diagnosis:  Eye disease from shingles affecting the cornea, within the past year

Principal Investigator: Marian Macsai, MD

IRB Approval Number: EH17-188

Sponsor:   National Eye Institute of the NIH

Contact:  Interested patients may contact Mira Shiloach at 847.657.1750, mshiloach@northshore.org

Open to Enrollment:  Yes

 

A Pilot Study For Efficacy and Safety of Glanatec® Ophthalmic Solution 0.4% on Corneal Edema And Endothelial Cell Counts in Subjects with Fuchs Endothelial Dystrophy

Aims: To investigate whether the drug Glanatec ® (which is approved in Japan for glaucoma and ocular hypertension) can be used in patients with Fuchs endothelial dystrophy who have had a Descemet stripping procedure without a corneal cell transplant

Diagnosis:  Fuchs Endothelial Dystrophy- visually significant

Principal Investigator: Marian Macsai, MD

IRB Approval Number: EH17-320

Sponsor: NorthShore University HealthSystem Foundation, Research and Education Fund

Contact:  Interested patients may contact Mira Shiloach at 847.657.1750, mshiloach@northshore.org

Open to Enrollment:  Yes

 

A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants with Previous NAION

Aims: To evaluate the efficacy and safety of RPh201 (a purified plant extract), administered twice weekly over 26 weeks, on visual function in patients with prior NAION.

Diagnosis:  Nonarterteritic anterior ischemic optic neuropathy (NAION) in the past 5 years.

Principal Investigator: John Pula, MD

IRB Approval Number: EH18-294

Sponsor: Regenera Pharma, Ltd.

Contact:  Interested patients may contact Mira Shiloach at 847.657.1750, mshiloach@northshore.org

Open to Enrollment:  Yes