CLINICAL TRIALS

Welcome to Southeast Retina Center – Clinical Trial Research Division!

Southeast Retina Center Clinical Trial Division has brought cutting edge therapies to our community and patients. Drs. Marcus and Poley have been clinical research investigators for many of the clinical trials investigating new state-of-the-art therapies for retinal diseases. Several of these therapies, such as anti-vascular endothelial growth factor (anti-VEGF) injections were evaluated in our office as part of clinical trials. Patients participating in clinical trials at Southeast Retina Center had the opportunity to receive therapies prior to their availability. Many treatments such as anti-VEGF injections were subsequently FDA approved and are now standard treatment for many blinding retinal disorders such as wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. Our clinical trial research division continues to study and evaluate new preventative and therapeutic treatments as we participate in numerous clinical trials and studies ranging from Phase I through Phase IV.


Our Physicians  are  national leaders in clinical research as they continue to offer our patients cutting edge therapies in trials sponsored by the National Eye Institute and

pharmaceutical companies. Our practice has participated in the internationally recognized, National Eye Institute-sponsored Diabetic Retinopathy Clinical Research (DRCR) Retina Network which is a leading entity for vital research for our diabetic patients. Dr. Marcus has served in several leadership roles for the Network including the DRCR executive committee, protocol chairman, DRCR writing committees and protocol development committees. Dr. Marcus is national protocol chairman for the DRCR Retina Protocol AA evaluating wide field imaging of the retina in diabetic retinopathy.  Wide field imaging may provide a more comfortable way for patients undergoing photography of their retinas. Dr. Marcus has served and continues to serve in a leadership position for several pharmaceutical study steering committees including evaluation of a surgically implanted device which slowly releases anti-VEGF medicine in the eye.  This device may potentially limit the number of eye injections a patient needs to have.  Dr. Marcus has helped in developing and revising the surgical technique for device placement and in study protocol development and oversight.  Dr. Marcus has devised unique approaches during the surgical removal of blood in diabetic eyes and has coined the term “endolaserless” surgical vitrectomy.  Dr. Marcus continues to study this technique within our clinical research unit as part of their clinical trial, known as the LASER LESS Trial.  With this technique our physicains are studying whether omitting laser during blood removal in a diabetic patient can lead to better vision while saving patients from the side effects of laser. 


Dr. Marcus and Dr. Poley are also studying various treatments for dry age-related macular degeneration with atrophy, where cells die off.  The is no current treatment for atrophy with advanced dry AMD, a vision problem occurring in 5 million persons worldwide.  Dry atrophic AMD clinical trials at our office include eye injections, subcutaneous (just under the skin) injections, gene testing and gene replacement injections and surgery.

Our dedicated Certified Research staff brings extensive experience in quality data capture, visual function examinations, ophthalmic photography, OCT  and OCT angiography, wide field retinal imaging, retinal visual field and  microperimetry testing , retinal electrophysiology and ultrasonography.  Our staff has cross-certification for various studies, strict protocol adherence and good clinical practice guidelines. Our site had been recognized as “Clinical Research Site of the Month” by the DRCR Retina network.

Our imaging section performs anterior and posterior segment photography/fluorescein and indocyanine green angiography, posterior segment OCT (Cirrus, Heidelberg Spectralis ), HRT III, Corneal Topography (, microperimetry, and diagnostic and biometric ultrasonography .The visual field section employs Humphrey perimeters and on-site electrophysiology testing. Biologic specimens are collected, centrifuged, stored (-20F and -86F freezers), packaged under CLIA accreditation and shipped by EHSO certified personnel.
This extensive experience in well-designed, controlled clinical trials has made us one of today’s nationally recognized leaders in retina based clinical research. Our doctors take pride in offering the most promising vision-saving treatment to our patients.

Why consider us for as your next Research Site?

Our Facility boasts:

  • 1000 sq ft. Dedicated Clinical research wing

  • State-of-the-art imaging /diagnostic equipment

  • Dedicated, visual acuity testing room

  • Designated monitoring rooms with high speed internet and phone access

  • 4 dedicated experienced Certified clinical research coordinators

  • Dedicated RNs able to participate in Infusion studies

  • CPR and ACLS certified RNs

  • Certified Ophthalmic Technicians and Photographers

  • Trained personnel for handling/preparing for transportation of dangerous goods

  • Practice of Good Clinical Practice guidelines

  • Customized standard operating procedures

  • Excellent subject retention

  • Direct oversight by PI/Research Director

 

CURRENT CLINICAL TRIALS

Our dedicated Research Department has active studies in Wet AMD, Geographic Atrophy, Diabetic Macular Edema, and Diabetic Retinopathy.
We are currently enrolling qualified candidates*

  • Wet Age-related Macular Degeneration

    • “Kodiak”

    • “Outlook”

    • “Xplore”

  • Dry Macular Degeneration with Geographic Atrophy

    • “Apellis 303/304”

    • “Gallego”

    • “Gemini”

    • “GTSCOPE”

    • “Ionis”

    • “Stealth”

  • Diabetic Macular Edema and Retinopathy

    • “Pagoda”

    • “Mylan”

    • “Pavillion"

  • Device Testing

    • “Topcon”

    • "Zeiss Wide Field Imaging"

 

UPCOMING TRIALS, RECRUITING SOON!

  • Wet Macular Degeneration:, 

  • Geographic Atrophy:

  • Diabetic Macular Edema: “, 

  • Diabetic Retinopathy: “, 

  • BRVO/CRVO:

  • Device Testing: “


For more information please email:  Siobhan Ortiz  siobhan@southeastretina.com

 

©2020 by Southeast Retina Center.