The Retina Institute of Virginia is an active participant in the Diabetic Retinopathy Clinical Research network (DRCR) and national research trials.  The tireless efforts of our patients and staff have led to the approval of many treatments now considered to be standard of care.  Our continuing efforts and involvement in clinical research will lead to superior treatments to ultimately preserve sight. 

Please call (804) 644-7478 for more information and participation criteria in our active clinical trials.

 Suzette Rosen, COA- Clinical Research Coordinator

CURRENT TRIALS


ALLERGAN CEDAR 150998-005 trial-
A two year Multicenter, Randomized, Double Masked, Parallel Group, Active Controlled Study To Assess The Safety and Efficacy of Abicipar Compared with Ranibizumab In Treatment Naïve Patients With Neovascular Age Related Macular Degeneration  (Active, enrollment closed)

OPH2003 Trial- A Phase 2b Randomized, Double Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura (Anti C5 Aptamer) in Subject with Geographic Atrophy Secondary to Dry Age Related Macular Degeneration (Active, enrollment closed)

RHINE DME Trial- A Phase III Multi-center, Randomized, double masked, Active Comparator Controlled Study to Evaluate the Efficacy and Safety of RO6867461 In Patients with Diabetic Macular Edema  (Active,  and open to enrollment)

ARCHWAY WET AMD SURGICAL Trial - 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 Degeneration (Active and open to enrollment)

MYLAN DME (BIOSIMILIAR) Trial – A Multicenter, 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  (Active and open to enrollment)

ALLERGAN MAPLE Trial – Evaluation of Abicipar Pegol in Patients with Neovascular Age Related Macular Degeneration (Active, enrollment closed)

MY RETINA TRACKER GENETIC TESTING Study- Foundation Fighting Blindness Registry Amendment 1. Feasibility of Enhancing the Data Value of the Patient Driven Registry My Retina Tracker through the Provision of Clinical Genetic Testing Services

ARTIC –Dry AMD Zinc Sensitivity Testing

 

 

DIABETIC RETINOPATHY CENTER RESEARCH TRIALS

DRCR.net PROTOCOL T-   A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema. Clinical trial completed)

DRCR.net PROTOCOL TX-   A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema Follow Up Extension study. Clinical trial completed)

DRCR.net PROTOCOL V- Treatment for Center Involved Diabetic Macula Edema in Eyes with Very Good Visual Acuity.  Clinical trial completed

DRCR.net Protocol U- Short-term Evaluation of Combination Corticosteroid + Anti- VEGF Treatment for Persistent Central-Involved Diabetic Macular Edema Following Anti-VEGF Therapy in Pseudophakic Eyes. Clinical trial completed

DRCR.net Protocol W- Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk (Active)

DRCR.net GENETICS STUDY- Genes in Diabetic Retinopathy Project (Active, and currently recruiting)


PREVIOUS CLINICAL TRIALS

UVEITIS

SAKURA DE-109- A Phase III, Multinational, Multicenter, Randomized, Double Masked Study Assessing the Safety and Efficacy of Intravitreal Injections of DE-109 (three doses) for the Treatment of active, Noninfectious Uveitis of the Posterior Segment of the eye. 

 

AGE RELATED MACULAR DEGENERATION

RTH258-C001 (HAWK) Trial- A Two Year Randomized, Double Masked, Multicenter, Three Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept (Eylea) in Subjects with Neovascular Age Related Macular Degeneration.   (closed)(Wet AMD Study)  

CHROMA Study- A Phase III multi-center, randomized, double masked, sham controlled study to assess the efficacy and safety of lampalizumab administered intravitreally to patients with geographic atrophy secondary to age related macular degeneration.  (closed) (DRY AMD STUDY)  

http://clinicaltrials.gov/show/NCT02247479

Clinicaltrials.gov identifier: NCT02022540

OMASPECT Study- A Phase III multi-center, randomized,   controlled study to assess the efficacy and safety of lampalizumab administered intravitreally to patients with geographic atrophy secondary to age related macular degeneration.  (closed) (DRY AMD STUDY

OPH1004B- A Phase III randomized, double masked, controlled trial to establish the safety and efficacy of Intravitreous administration of Fovista (Anti PDGF-B PEGylated aptamer) administered in combination with either Avastin ® or Eylea ® compared to Avastin ® or Eylea ® monotherapy in subjects with Sub foveal Neovascular age related macular degeneration.  (Closed) (WET AMD STUDY)

TYROGENEX X-82- A Randomized, Double- Masked, Placebo-Controlled, Dose-Finding, Non-Inferiority Study of X-82 plus prn Eylea compared to prn Eylea monotherapy in neovascular AMD (closed  (WET AMD STUDY)

Genentech HARBOR study- A Phase III, Double Masked, Multicenter, Randomized, Active Treatment Controlled Study Of the Efficacy and Safety of 0.5mg and 2.0mg Ranibizumab Administered Monthly or on an as needed basis (PRN) in patients with Subfoveal Neovascular age related macular degeneration (wet AMD). (Closed)


DIABETIC RETINOPATHY

Genentech RISE study- A Phase III, Double Masked, Multicenter, Randomized, Sham injection controlled study of the efficacy and safety of Ranibizumab injection in subjects with clinically significant macular edema with center involvement secondary to diabetes

MATISSE study-  An open label dose escalation study of PF-04523655 (STRATUM I) combined with a prospective, randomized double masked, multi center, controlled study (STRATUM II) Ranibizumab versus Ranibizumab alone in Diabetic macular edema


OTHER

AKORN AK1015- A Randomized, Prospective, Sham controlled, Multicentered Clinical Trial Using 1.5%, 2.5% and 3.5% Lidocaine topical gel (AK1015) versus sham control for Ocular Anesthesia

 

Please call 804 644 7478 for more information and participation criteria in our active clinical trials.

Suzette Rosen, COA- Clinical Research Coordinator