Michael W. Stewart, M.D.

Closed for Enrollment

• A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KINGFISHER) (DME) Jacksonville, Fla.

  The purpose of this study is to evaluate the effectiveness and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).

• A 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 (AMD) (PANDA-1) ((PANDA-1)) Jacksonville, Fla. The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.
• A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (ALXN2040) Jacksonville, Fla.

  The purposes of this study are to find out whether danicopan can slow the rate of geographic atrophy (GA) disease progression and slow the loss of visual function, to see how safe danicopan is for patients with GA by monitoring for any side effects, to see how the body responds to treatment with danicopan, to measure the levels of danicopan in blood over time, to find a safe and effective dose in patients with GA and how the body deals with the study drug at different dose levels, and to see the effect of danicopan on health-related quality of life, on activities of daily living, and on visual functions.

   

• A Phase 2, Double-Masked, Randomized, Controlled, Multiple-Dose, Regimen-Ranging Study of the Efficacy and Safety of Intravitreal REGN2176-3 in Patients with Neovascular Age-Related Macular Degeneration Jacksonville, Fla.

  The purpose of this study is to explore the safety and effectiveness of REGN2176-3 on visual acuity in patients with neovascular age-related macular degeneration compared to using intravitreal aflibercept injection monotherapy.

• A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye. (LUMINA) Jacksonville, Fla.

  The purpose of this study is to assess the effectiveness and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.

• CEDAR - Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR) Jacksonville, Fla.

  The purpose of this study is to assess the safety and effectivness of abicipar pegol in patients with neovascular age-related macular degeneration.

• The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension Jacksonville, Fla.

  This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.