Welcome to Southeast Retina Center – Clinical Trial Research Division!

Clinical Trials

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.

Upcoming Trials - Recruiting Soon!

1.   A Phase III Randomized Double -Masked Study of ABP 938 Efficacy and Safety Compared to Aflibercept in subjects with Neovascular Age related Macular Degeneration Protocol # : 20170542  (Amgen AMD)

2.   Study assessing the interest and availability of patients for clinical trials to explore the safety and efficacy of adeno-associated virus (AAV)-mediated gene therapy for X-Linked Retinitis Pigmentosa (XLRP). (AGTC)

 1.   A Study to assess the Safety, tolerability, and Pharmacokinetics of single rising intravitreal doses of BI 754132 in patients with geographic atrophy secondary to age related macular degeneration (Open label non-randomized uncontrolled) Protocol #: 1481-001.

2.  A Phase II/III Randomized, Double-Masked, Active-Controlled Study of the Efficacy and Safety of High-Dose Aflibercept in Patients with Diabetic Macular Edema.    Protocol # : VGFTe-HD-DME-1934

3.   A randomized active controlled subject and investigator masked multiple dose proof of concept study of intravitreal LKA651 in patients with Diabetic macular Edema .

 

Why Choose us?
  • 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 accessDesignated 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*

1. A Phase IIb Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of a Long-acting Intravitreal Sunitinib Malate Depot Formulation (GB-102) Compared to Intravitreal Aflibercept in Subjects with Neovascular (Wet) Age-related Macular Degeneration (Altissimo Study) Protocol # : GBV-102-002 / 1011627.( Graybug Vision)

2. A Phase II /III Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age related Macular Degeneration , Protocol # :KHB-1802, Version 1.0 (Panda)

3. A multicenter, open-label extension study to evaluate the long-term safety and tolerability of the port delivery system with ranibizumab in patients with neovascular age-related macular degeneration Protocol # : Gr40549 (Portal )
4. A Phase III, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety Offaricimab in patients with neovascular age-related macular degeneration Protocol #: GR40844 (Lucerne)

5. A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane versus Lucentis® in Patients with Neovascular Age-Related Macular Degeneration Protocol #: XBR1001 (Xplore)

6. A Phase II, Prospective, Randomized, Double-masked, Active Comparator controlled, multicenter Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects with Neovascular (Wet) Age-related Macular Degeneration Protocol #: KSI-CL-102 (Kodiak)

7. A Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects with Sub foveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) Protocol #: ONS-5010-002
(Outlook Therapeutics Inc.)

8. A Phase III, Multicenter, Randomized, visual assessor masked, active-comparator study of the efficacy, safety, and pharmacokinetics of the port delivery system with Ranibizumab in patients with neovascular age-related macular degermation) Protocol #: GR40548 (Archway)

9. Endolaserless Vitrectomy with Intravitreal Aflibercept Injection for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage Protocol # :VGTE-DR-1548 (Laserless )

1. A Study of Disease Progression in Genetically Defined Subjects with Geographic
Atrophy Secondary to Age-Related Macular Degeneration. - Protocol: Gtscope

2. A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) Short Title: Oaks Protocol # APL2-304 (Appellis)

3. A Phase II, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects with Age-Related Macular Degeneration with Geographic Atrophy Protocol# : SPIAM-202 (Stealth)

4. A Phase II, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)” Protocol #: ISIS 696844-CS5, (Ionis Pharmaceuticals, Inc.)

5. A Prospective Natural History Study to Evaluate Clinical Characteristics and Disease Progression in Subjects with Non-central Geographic Atrophy (GA) Who Are Carriers of High-risk Genetic Variants of Complement Factor H (CFH)” Protocol # : Gemini OBS GEM-NH 002 (Gemini)

6. A Phase I, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients with Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103 Protocol #: GEM-CL-10301

7. A Phase III multicenter, randomized, double-masked, sham controlled clinical trial to assess the safety and efficacy of intravitreal administration of Zimura™ (complement c5 inhibitor) in patients with geographic atrophy secondary to dry age-related macular degeneration . Protocol #: ISEE2008 (Zimura)

8. A Phase II multicenter, randomized, single-masked, sham controlled clinical trial to assess the safety ,Tolerability, and efficacy of intravitreal injections of FHTR2163 in patients with geographic atrophy secondary to age-related macular degeneration . Protocol #: GR40973 (Gallego)

1. A Phase II /III Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects with Diabetic Macular Edema -Protocol # MYL-1701P-3001 (Mylan)

2. DRCR Protocol AC- Randomized Trial of Intravitreous Aflibercept versus Intravitreous Bevacizumab + Deferred Aflibercept for Treatment of Central-Involved Diabetic Macular Edema

3. DRCR Protocol AE- A Pilot study evaluating Photo biomodulation Therapy for DME

4. A Phase III, multicenter, randomized, visual assessor masked, active comparator study of the efficacy, safety, and pharmacokinetics of the port delivery system with ranibizumab in patients with diabetic macular edema Protocol #: GR40550 (Pagoda)

5. A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 In Patients with Diabetic Macular Edema (RHINE) Protocol #: GR40398 (Rhine)

6. A Phase III, multicenter, randomized study of the efficacy, safety, and pharmacokinetics of the port delivery system with ranibizumab in patients with diabetic retinopathy (pavilion) Protocol # : GR41675 (Pavilion)

1. Topcon DRI OCT Triton with SS-OCT Angio Software Evaluation PreStudy. Protocol # : Triton OCT-A

2. Zeiss wide field Imaging

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.

 
 
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