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Diabetic Retinopathy Trials
At University Retina, we have a full-time team dedicated to our clinical trials program and are able to offer our patients the latest drugs and medical devices for treating retinal and macular diseases. If you are interested in learning more or participating in a clinical trial for retinal vein occlusion, please email us using the contact button below.
Director of Clinical Research
Veeral Sheth, MD, FACS
Current Clinical Trials
- Verona (EYP-1901-202): A phase 2, Multicenter, Prospective, Randomized, Single-Masked, Controlled Study of EYP-1901 (Vorolanib) Insert, a Tyrosine Kinase Inhibitor (TKI), Compared to Afibercept in Subjects with Diabetic Macular Edema (DME)
- Unity 4 (UBX1325-04): A Phase 2b, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients with Diabetic Macular Edema (Aspire)
- Perfuse (PER001-202): A Phase 2a Study to Evaluate Safety and Tolerability after Single Administration of Per-001 Intravitreal Implant in Participants with Diabetic Retinopathy.
Completed Clinical Trials
- Canberra Study A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy The study’s main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.Sponsors: Genentech, Inc. & Hoffmann-La RocheRead about the study on clinicaltrials.gov, here.
- Pagoda Study This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal RanibizumabThis study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).Sponsor: Genentech, Inc. & Hoffmann-La RocheRead about the study on clinicaltrials.gov, here.
- Pavilion Study A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator ArmStudy GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm. Sponsor: Genentech, Inc. Read about the study on clinicaltrials.gov, here.
- Photon Study of a High-Dose Aflibercept in Participants With Diabetic Eye DiseaseThe primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.The secondary objectives of the study are as follows:To determine the effect of HD vs. aflibercept on anatomic and other visual measures of responseTo evaluate the safety, immunogenicity, and pharmacokinetics (PK) of afliberceptSponsors: Regeneron Pharmaceuticals & BayerRead about the study on clinicaltrials.gov, here.
- Kingfisher Study Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (DME) The purpose of this study is to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to DME. In this 12-month, randomized, double-masked, multicenter, active controlled study, consenting patients will be randomized in a 2:1 ratio (brolucizumab: aflibercept) and attend 15 planned visits. Sponsor: Novartis PharmaceuticalsRead about the study on clinicaltrial.gov, here.
- Rhine Study A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).Sponsor: Hoffmann-La RocheRead about the study on clinicaltrial.gov, here.
- Rhone-X Study A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular EdemaThis is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.Sponsor: Hoffmann-La RocheRead about the study on clinicaltrial.gov, here.
- Alimera Study
- Cool-3 Study
- Norse-3 A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal DisordersA 3-month study to assess the safety of ophthalmic bevacizumab (ONS-5010) in subjects with visual impairment diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab due to retinal disorders: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion. Sponsor: Outlook Therapeutics, Inc. Read about the study on clinicaltrials.gov, here.
- The TIME-2b Study A Study of AKB-9778, a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR) The purpose of this study is to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR).Sponsor: Aerpio Therapeutics, Inc.Read more about the study on clinicaltrials.gov, here.
- Panorama StudyA phase 3, double-masked, randomized study of the efficacy and safety of intravitreal aflibercept injection in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). Sponsor: Regeneron Pharmaceuticals, Inc.
- Boulevard StudyA multiple center, multiple dose, randomized, active comparator controlled, double-masked, parallel group, 24-week study to investigate the safety, tolerability, pharmacokinetics, and efficacy of RO6867461 administered intravitreally in patients with diabetic macular edema. Sponsors: Genentech, Inc. & F. Hoffmann-La Roche AG
- Protocol AC Study
- ILUVIEN® (Paladin) StudyA Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg ILUVIEN is a microimplant designed to release a continuous, low-dose treatment to the retina for up to 36 months to help maintain consistent vision longer. The medicine in ILUVIEN is called fluocinolone acetonide (FAc), a type of steroid called a corticosteroid. FAc helps treat the inflammation associated with diabetic macular edema (DME). Sponsor: ILUVIEN®
- Protocol OPH1006 StudyAn 18 month phase 2a open label, randomized study of Avastin, Lucentis, or Eylea (anti-VEGF therapy) administered in combination with Fovista (anti-PDGF BB pegylated aptamer). Sponsor: Iveric Bio
- Protocol OPH1004 StudyA phase 3 safety and efficacy study of Fovista intravitreous administration in combination with either Avastin or Eylea compared to Avastin or Eylea monotherapy. Sponsor: Iveric Bio
- ORBIT Study StudyPhase 4 study of intravitreal Jetrea for vitreomacular adhesion. Sponsor: Oxurion
