Clinical Trials


Overview

The AIO Research Division is dedicated to contributing to the global effort to alleviate diseases of the eye through teaching and research. Serving as a world-class research and educational organization, we are dedicated to the preservation and restoration of vision.

The Research Institute Staff:

  • Miguel Busquets, MD, FACS - Director
  • Lesley Holot, BS - Manager
  • Ginger Hazelbaker - Study Coordinator
  • Rebecca Poyma, NCMA - Study Coordinator
  • Kelly Szabo, BS, MPH - Study Coordinator

Previous Trials:
The Research Institute of AIO has been involved with FDA trials since 2003. They have included treatment for Cataracts, Conjunctivitis, Corneal Infiltrates, CME from BRVO/CRVO, ARMD, NPDR, and Glaucoma.

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General Public and Sponsors

Our Research Division is involved in numerous FDA-sponsored, national multicenter clinical trials that enable eligible patients to have access to new therapies and technologies not yet available to the general public. Pharmaceutical and surgical companies partner with AIO for the purpose of conducting these clinical trials. Here at AIO we offer patients who enroll in our clinical trial studies the most advanced treatments and medicines not yet available to the public.

Clinical trials are necessary to develop new medications to treat medical conditions or to improve existing ones. There are four phases of clinical research.

PHASE ONE: This phase consists of testing new medications or products on humans. It is done in a small number of healthy volunteers (20 to 100 persons). In this phase, the medication or product is tested for safety.

PHASE TWO: During this phase, once the drug or product is proven to be safe, it will be tested for efficacy (the capacity to produce a desired effect under ideal or optimal conditions). This phase of testing may last from several months to two years and involves up to several hundred patients.

PHASE THREE: In a phase III study, a drug or product is tested on several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits and the range of possible adverse reactions. Pharmaceutical companies can request FDA approval for marketing the drug after the successful completion of this phase.

PHASE FOUR: In phase IV studies, pharmaceutical companies have several objectives: (1) a drug may be compared with other drugs already on the market; (2) a drug's long-term effectiveness and impact on a patient's quality of life may be assessed; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and newer therapies.

All clinical trials are regulated/monitored by the FDA and an Independent Review Board (IRB).

Please ask your physician if you might qualify for a clinical trial related to your eye condition.

You may also be compensated for your time associated with a clinical trial.

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Current Studies

Regeneron: VIBRANT Study. Double-masked, randomized, active-controlled study of the efficacy, safety and tolerability of intravitreal VEGF trap-eye in patients with Macular Edema secondary to Branch Retinal Vein Occlusion.

Principal Investigator: Miguel Busquets, MD, FACS
Sub-Investigators: Brian Jewart, MD; Gabriel Benitez, MD; David Rabady, MD

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Transcend Medical: COMPASS Trial. Prospective, randomized, comparative, multicenter clinical study to assess the safety and effectiveness of the Transcend Cypass Glaucoma Implant in patients with Open-angle Glaucoma undergoing Cataract surgery.

Principal Investigator: John Nairn, MD
Sub-Investigators: Lisa Cibik, MD, FACS; Gregory Dziubek, OD; George Grisnik, OD; Chris Cakanac, OD; Ryan McBee, OD

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Alcon: ReSTOR Study. Prospective, subject-masked, observer-masked, randomized, parallel group study where subjects bilaterally implanted with either the investigational ACRYSOF IQ ReSTOR +2.5 D Multifocal IOL or FDA-approved ACRYSOF IQ IOL.

Principal Investigator: Lisa Cibik, MD, FACS
Sub-Investigators: John Nairn, MD; Ryan McBee, OD

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Alcon: TORIC Study. Prospective, non-randomized, unmasked study where subjects with pre-existing corneal astigmatism ≥ 2.57 D choose to be implanted with either the Acrysof IQ Toric High Cylinder Power IOL or the Acrysof IQ Aspheric NATURAL IOL

Principal Investigator: Lisa Cibik, MD, FACS
Sub-Investigators: John Nairn, MD; K. Anne Jacobs, MD; Ryan McBee, OD

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Allergan: BDP Study. Multi-center, 2 Stage (Open Label, Dose Escalation, Followed by Masked, Randomized) Single Dose Study of the safety and efficacy of AGN-208397 in patients with Macular Edema associated with Retinal Vein Occlusion.

Principal Investigator: Miguel Busquets, MD, FACS
Sub-Investigators: Brian Jewart, MD; Gabriel Benitez, MD

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LPath: NEXUS Study. Multi-center, masked, randomized, comparator-controlled study evaluating ISONEP as either monotherapy or adjunctive therapy to Lucentis or Avastin versus Lucentis or Avastin alone for the treatment of subjects with Choroidal Neovascularization secondary to ARMD.

Principal Investigator: Miguel Busquets, MD, FACS
Sub-Investigators: Brian Jewart MD, Gabriel Benitez, MD

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XOMA: EYEGUARD Study. Randomized, double-masked, placebo-controlled study of the safety and efficacy of Gevokizumab in the treatment of active, non-infectious intermediate, posterior or Pan-Uveitis.

Principal Investigator: Miguel Busquets, MD, FACS
Sub-Investigators: Brian Jewart, MD; Gabriel Benitez, MD

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Regeneron: VIEW I Study Extension. Double-masked, active-controlled study of the efficacy, safety and tolerability of repeated doses of intravitreal VEGF trap in patients with neovascular ARMD.

Principal Investigator: Miguel Busquets, MD, FACS
Sub-Investigators: Brian Jewart, MD

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Genentech: RIDE Study. Controlled study of the efficacy and safety of Ranibizumab injection in subjects with clinically significant macular edema with center involvement secondary to DM.

Principal Investigator: Brian Jewart, MD
Sub-Investigators: Miguel Busquets, MD, FACS; Gabriel Benitez, MD

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GlaxoSmithKline: A phase 2, multi-centre, randomized, double-masked, placebo­ controlled, parallel-group study to investigate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GSK933776 in adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Principal Investigator: Miguel Busquets, MD, FACS
Sub-Investigators: Brian Jewart, MD; Gabriel Benitez, MD; David Rabady, MD

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Investigator Sponsored (In-House) Studies

Macugen: Pan-retinal laser Endophotocoagulation for the treatment of proliferative diabetic retinopathy.
Triple Therapy Study: An Evaluation of the safety and efficacy of Triple Therapy for subfoveal choroidal neovascularization (CNV) secondary to age related macular degeneration (ARMD).

Contact information:

Lesley Holot, Research Manager
9970 Mountain View Drive, 2nd Floor
West Mifflin, PA 15122
Phone: 412-653-3080 x1041
Fax: 412-653-3698

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Center Overview

AIO has been providing quality eye care for over a century in southwestern Pennsylvania. AIO provides patients with a full range of vision services using state-of-the-art technology. The Pittsburgh area eye surgeons (eye doctors), are board-certified and fellowship trained in their specific areas of expertise. Our surgeons specialize in the diagnosis and treatment of cataracts, diseases of the cornea, retina (including diabetic retinopathy, diabetic eye care, macular degeneration, retinal detachments, flashes and floaters), glaucoma, and vision correction surgery (CustomCornea® Lasik).

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Clinical Research Experience

The Research Department has been participating in clinical trial studies since 2003 and has conducted many different types of clinical trial studies related to eye diseases and disorders.

This work has allowed us to partner with the following sponsors and CRO's in conducting clinical trial studies:
•Alcon
•Allergan
•Alimera
•Bausch & Lomb
•Chiltern
•DRCR (Diabetic Retinopathy Clinical Research Network)
•Eli-Lilly
•Genentech
•Glaukos
•Icon
•Kendle
•Neo-Vista
•Novartis
•Ophthotech
•OSI Pharmaceuticals
•Parexel
•LPath
•PPD
•Regeneron
•Transcend Medical

The Research Center and main office:

West Mifflin Office and Surgery Center
9970 Mountain View Drive
West Mifflin, PA 15122
412-653-3080

Other offices:

Butler Office
120 Hollywood Drive, Suite 103
Butler, PA 16001
724-282-9547

Greensburg Office
2000 Tower Way, Suite 2037
Greensburg, PA 15601
724-837-5834

Meadville Office
(Retinal Patients Only)
390 Linden Street
Meadville, PA 16335
1-888-634-9800

Monroeville Office
2790 Mosside Blvd, Suite 200
Monroeville, PA 15146
412-373-3344

Uniontown Office
97 Delaware Avenue
Uniontown, PA 15401
724-439-4250

Wheeling, WV Office
20 Medical Park, Suite 105
Wheeling, WV 26003
1-888-634-9800

 

Contact Information:
Sponsors, please contact:
Lesley Holot, Research Manager
9970 Mountain View Drive, 2nd Floor
West Mifflin, PA 15122
Phone: 412-653-3080 x1041
Fax: 412-653-3698

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Investigator Experience

Currently, our board-certified ophthalmologists include:

Miguel Busquets, MD, FACS is Director of the Research Department and a board- certified, fellowship trained vitreo-retinal surgeon. Dr. Busquets is actively involved in groundbreaking research relating to retinal diseases and is a Principal Investigator for several national sponsored clinical trials. He is the author of numerous publications in this field and lectures on these topics at national and international conferences.

Lisa Cibik, MD, FACS is the Director of Cataract Services at Associates in Ophthalmology. She is a board-certified surgeon and has lectured nationally on advancements in cataract removal techniques and technology. Dr. Cibik is a Principal Investigator and is involved with studies of new ophthalmic medications and devices.

Brian Jewart, MD is a board-certified, fellowship trained vitreo-retinal surgeon. Dr. Jewart has authored and co-authored many publications and has given multiple presentations. He also is featured in patient educational videos and has achieved national recognition for his video about diabetic retinopathy. Dr. Jewart is a Principal Investigator and is involved with nationally sponsored clinical trials.

John Nairn, MD is a board-certified, fellowship trained glaucoma specialist. He has published numerous articles on glaucoma surgery and has lectured extensively throughout the country on the subject. Dr. Nairn has been involved as a Principal Investigator with national clinical studies involving glaucoma related studies.

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