The Clinical Research Center at Vitreoretinal Consultants currently conducts over twenty FDA and NIH sponsored clinical trials on age related macular degeneration, diabetic retinopathy, and other retinal diseases. Recent accomplishments of the center include being the leading worldwide site for the first agent to show overall visual acuity improvement in an age-related macular degeneration trial.
These trials are investigating Ranibizumab (rhuFab), an anti-angiogenic anti-VEGF monoclonal antibody fragment which serves to stop new blood vessel formation and decrease leakage form abnormal blood vessels in patients with "wet" age-related macular degeneration. The goal of these trials is to reverse the damage caused by new blood vessel growth; thereby halting decreasing vision, and even possibly improving vision. Ongoing trials are investigating the use of Lucentis in occult, minimally classic, and predominantly classic CNVM and with differing dosage intervals.
Sponsored by Genentech, Inc.
Trials are ongoing utilizing pegaptinib sodium (Macugen), an anti-angiogenic VEGF-165 specific-binding molecule, administered intravitreously, alone and in combination with Visudyne Photodynamic Therapy (PDT) to reduce and prevent the formation of new blood vessel growth in subjects with "wet" age-related macular degeneration. The goal of these trials are to reverse the damage caused by new blood vessel growth; thereby halting decreasing vision, and even possibly improving vision.
Sponsored by Eyetech & Pfizer Pharmaceuticals
This trial utilizes Anecortave Acetate, an anti-angiogenic factor, to prevent the onset of new blood vessel growth (also called "Wet" AMD) in subjects with "dry" age-related macular degeneration (AMD). By functioning as a preventative treatment, the goal of this clinical trial is to prevent the growth of new blood vessels, thereby preventing vision loss before it happens.
Sponsored by Alcon Pharmaceuticals
This trial utilizes an investigational anti-angiogenic drug (called AG-013958), a VEGF receptor blocking molecule, administered in a Sub-Tenon's injection, to reduce and prevent the formation of new blood vessel growth in subjects with "wet" age-related macular degeneration. By blocking the receptors which interact with VEGF (a promoter of new blood vessel growth and leakage), this trial aims to reduce and reverse the damage brought upon by new blood vessel growth and potentially restore lost vision.
Sponsored by Pfizer Pharmaceuticals
Trials are ongoing utilizing pegaptinib sodium (Macugen), an anti-angiogenic VEGF-165 specific-binding molecule, administered intravitreously, to prevent the formation of new blood vessel growth in subjects previous treated for “wet” age-related macular degeneration. The goal of these trials are to prevent the recurrence of blood vessel growth and the damage caused by such blood vessels; thereby preventing decreasing vision, and even possibly improving vision.
Sponsored by Eyetech & Pfizer Pharmaceuticals
This trial utilizes a new anti-angiogenic drug (called AG-013958), a VEGF receptor blocking molecule, administered in an intravitreal injection, to reduce and prevent the formation of new blood vessel growth in subjects with “wet” age-related macular degeneration. By blocking the receptors that interact with VEGF (a promoter of new blood vessel growth and leakage), this trial aims to reduce and reverse the damage brought upon by new blood vessel growth and potentially restore lost vision.
Sponsored by Pfizer Pharmaceuticals
This trial utilizes a new anti-angiogenic drug called a VEGF-Trap, a VEGF-inhibiting molecule, administered in an intravitreal injection, to reduce and prevent the formation of new blood vessel growth in subjects with “wet” age-related macular degeneration. This trial aims to reduce and reverse the damage brought upon by new blood vessel growth and potentially restore lost vision.
Sponsored by Regeneron Pharmaceuticals
This trial utilizes fluocinolone acetonide (ASI-001A 0.5ug and ASI-001B 0.2ug) intravitreal inserts to determine the safety and efficacy in the patients with diabetic macular edema. This trial aims to reduce and reverse the damage brought macular edema and potentially restore lost vision.
Sponsored by Alimera Sciences
Vitreoretinal Consultants is participating in several trials examining the potential differences and benefits of Triamcinolone Acetonide, administered intravitreously, compared to Laser therapy or in dose dependant settings compared with Laser Therapy in the treatment of diabetic macular edema. The goal and possible benefits of these trials are decreases in vision loss, as well as possible improvement of vision.
Sponsored by the National Eye Institute (NEI) and the Diabetic Retinopathy Clinical Research Network (DRCR)
This Phase 3 trial studies the safety and efficacy of a new investigational drug treatment for diabetic macular edema. Qualified participants must be 18 years or older, be diagnosed with type 1 or type 2 diabetes and have developed macular edema associated with diabetic retinopathy. Qualified participants will receive study-related medication and care, lab tests, and eye examinations at no cost.
Sponsored by Allergan Pharmaceuticals
The RAVE (Rubeosis Anit-VEgf) trial, sponsored in part by Vitreoretinal Consultants, utilizes Ranibizumab (rhuFab), an anti-angiogenic anti-VEGF monoclonal antibody fragment to study whether it will stop new blood vessel formation in patients with ischemic Central Retinal Vein Occlusions. The goal of this trial is to test if total VEGF blockade will prevent neovascular glaucoma and the devastating complications seen in up to 50% of patients with this untreatable disease.
Sponsored by Vitreoretinal Consultants and Genentech, Inc.
The purpose of this trial is to examine the potential differences and benefits of Triamcinolone Acetonide, administered intravitreously, compared to Laser therapy in the treatment of both central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). The goal and possible benefits of this trial are decreases in vision loss, as well as possible improvement of vision.
Sponsored by the National Eye Institute (NEI)
This Phase 3 trial studies the safety and efficacy of a new investigational drug treatment for macular edema due to central or branch retinal vein occlusion. Qualified participants be 18 years or older, be diagnosed with macular edema or swelling in the back of the eye and not have a history of glaucoma or diabetic retinopathy. Qualified participants will receive study-related medication and care, lab tests, and eye examinations at no cost.
Sponsored by Allergan Pharmaceuticals
This trial utilizes pegaptinib sodium (Macugen), an anti-angiogenic VEGF-165 specific binding molecule, administered intravitreously to reduce macular edema in subjects with non-ischemic central retinal vein occlusion (CRVO). The goal of this trial is to reverse the leakage and edema caused by blockage in the central retinal vein in attempt to obtain better long-term visual outcomes.
Sponsored by Eyetech & Pfizer Pharmaceuticals
The purpose of this trial is to evaluate and determine the safety and efficacy of Combretastatin A4 Phosphate, a naturally occurring molecule that binds tubulin and suppresses VEGF-induced blood vessel growth, administered by intravenous injection, for treating and preventing new blood vessel growth in patients with pathologic myopia. Although patients may receive no direct benefit from participation in this research study, participation may provide benefit to many future patients who suffer with the same condition.
Sponsored by OxiGene, Inc.
This study is designed to help develop a more effective irrigation solution for use during ocular surgery vitrectomies, specifically epimacular membrane surgeries. The solution is called Next Generation Ophthalmic Irrigation Solution (NGOIS). Patients are seen at the main office in the medical center for all 6 appointments that are necessary for this study.
Sponsored by Matthew S. Benz, MD
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