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Current Clinical Trials

EyePoint Lugano - Actively Enrolling - NEW

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  • A randomized, double-masked, multicenter, phase 3 study evaluating EYP-1901 (tyrosine-kinase inhibitor) vs Eylea 2 mg in treatment-naive and previously treated wet age-related macular degeneration.

    • ​Sponsor: EyePoint 

    • Length of Study: 96 Weeks (26 visits)

    • Treatment: Eylea X3 monthly, then EYP-1901 vs Aflibercept 2 mg q8 weeks

    • Treatment-naive and treatment-experienced patients with wet AMD

      • OK to have prior treatment...​

        • Must have been treated with 2+ anti-VEGF injections in the last 6 months.

        • Last injection at least 6 weeks prior from screening

    • BCVA 20/32 - 20/200 in the study eye

    • No subfoveal fibrosis, atrophy or scarring

    • Fellow eye, BCVA must be better or equal than 20/400

    • Must have fluid on OCT at time of screening

    • Total area of CNV >50% of total lesion area

    • Prior use of focal laser, Syfovre or Izervay is not allowed

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Consent form available here to print. (Last updated October 9, 2024)​

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​​​​EyeBio Brunello - Actively Enrolling - NEW

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  • A randomized, double-masked, multicenter, three-arm pviotal phase 2/3 study to evaluate the efficacy and safety of intravitreal EYE103 compared with intravitreal ranibizumab (0.5 mg) in participants with diabetic macular edema (DME).

    • ​Sponsor: EyeBiotech

    • Length of Study: 100 Weeks (2 years; 22 visits)

    • Treatment: EYE103 (0.5 mg or 0.8 mg) vs Ranibizumab 0.5 mg

    • Treatment-naive and treatment-experienced patients with DME

      • OK to have prior treatment with the following washout:​

        • Eylea HD or Vabysmo (6 months)​

        • Other anti-VEGF (3 months)

        • Ozurdex (6 months)

        • PRP or focal laser (3 months)

      • First treatment must be no longer than 3 years ago​

      • If treatment naive, diagnosis of DME within the last 9 months.

    • BCVA 20/32 - 20/320 in the study eye

    • HbA1c ≤ 12%

    • CMT ≥ 325 microns

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Consent form available here to print. (Last updated August 25, 2024)​

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Kyowa Kirin – Actively Enrolling

  • A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Center-Involving Diabetic Macular Edema. â€‹

    • Sponsor: Kyowa Kirin Co. 

    • Length of Study: 56 Weeks (16 visits)

    • Treatment: KHK4951 eye drops vs. Placebo (after four aflibercept/Eylea injections during run in period)

    • BCVA 20/40 to 20/200 (73-35 letters)

    • CST ≥ 315 μm on OCT (max 500 μm)

    • Hemoglobin A1c ≤ 11%

    • ​No kidney dialysis

    • No previous:

      • Treatment with any IVT anti-VEGF drugs

      • Use of sub-Tenon or IVT corticosteroids

      • Ozurdex or Iluvien implant

      • PRP or Laser

  • Previously treated patients OK if Avastin, Eylea, Lucentis, Biosimilars, at least 12 weeks prior. ​​

    • No previous... subtenon or intravitreal steroids, Ozurdex, Iluvien, PRP, or focal laser. 

  • Note, BP needs to be below 140/90 mmHg (no more than 3 anti-hypertensive medications)

  • More information can be found here.

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Consent form available here to print. â€‹(Last updated July 17, 2024)

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Oculis DX219, Diamond – Actively Enrolling

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  • A Phase 2/3 Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye drops in Subjects with Center-Involving Diabetic Macular Edema (DME). â€‹

    • Sponsor: Oculis SA

    • Length of Study: 52 Weeks (12 visits)

    • Treatment: OCS-01 Eye Drops vs. Placebo

    • OK to have prior treatment, with the following washout period in parenthesis:

      • Anti-VEGF (3 months)

      • Ozurdex (6 months)

      • Triamcinolone - IVT and periocular (4 months)

      • PRP (0 months) 

      • PPV/eye surgery (0 months)

    • BCVA  ≥ 20/50 - 20/320 (65 to 24 letters) in the SE and > 20/200 (34 letters) in the non-study eye

    • CMT ≥ 310 μm

    • HbA1c ≤ 10%

    • 18-85 years of age

    • Dialysis patients are eligible

  • More information can be found here.

 

Consent form available here to print. (Last updated April 17, 2024)​​

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Kodiak Sciences Inc, GLOW2 – Actively Enrolling

  • A Prospective, Randomized, Double-masked, Sham controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) – GLOW2.

    • Sponsor: Kodiak 

    • Length of Study: 48 Weeks (8 visits, 5 injections)

    • Treatment: Tarcocimab 5mg vs. Sham

    • Treatment-naive Moderately Severe to Severe NPDR (DRSS 47-53)

      • Update 10/14/24 - patients with mild PDR (DRSS 61) may be included.

    • CST ≤ 320 μm and BCVA 20/40 or better.... or CST > 320 and ≤ 350 and BCVA 20/25 or better 

    • Fellow eye BCVA CF or better 

    • No prior PPV, PRP, anti-VEGF, or steroid injection 

      • Update 10/14/24 - patients with prior anti-VEGF for DR or DME can be included if last treatment was one year prior to Day 1 visit. ​

    • No current vitreous hemorrhage 

    • HbA1c ≤ 12%

    • No kidney dialysis

  • More information can be found here.

 

Consent form available here to print. (Last updated October 8, 2024)​

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OnPoint Vision – Actively Enrolling

  • Study to Evaluate the Safety and Effectiveness of the AccuraSee IOPCL for Secondary Implantation in the Capsular Bag to Improve Intermediate and Near Vision following Previous Cataract Surgery.​

    • Sponsor: OnPoint Vision Inc.

    • Length of Study: 36mos + 24m post market study (11 visits) 

    • Evaluate the safety and efficacy of the IOPCL for

    • Secondary implantation in the capsular bag to improve near vision in subjects with ARMD after cataract surgery.

    • Subjects with Stable dry AMD/wet AMD x6mos

    • Approved IOLs: Alcon, SN60WF, SA60WF, SN60AT, ZA9003, ZCB00, (PCB00) Carl Zeiss CT Lucia (602).

    • BCVA 20/80 - 20/160 in surgery eye (non-dominant eye).

    • FE BCVA 20/63 or worse.

    • No Glaucoma.

    • No history of RD.

    • Low vision evaluation is needed before consent.

  • More information can be found here.

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Sandcat – Enrollment Closed, but Study Active

  • Multicenter, Randomized, Double-masked, Sham controlled study to investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered IVT in Patients with Uveitic Macular Edema.

  • More information can be found here.

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Formycon – Enrollment Closed

  • An Open-Label, Multi-Center, Single-Arm study to evaluate the ocular safety and usability of FYB203 Pre-filled Syringe (PFS) in patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema, or Diabetic Retinopathy. â€‹â€‹

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Parasol – Enrollment Closed, but Study Active

  • A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD).​​

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​Quasar – Enrollment Closed, but Study Active

  • Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion.​

  • More information can be found here.

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Clearside Odyssey – Enrollment Closed, but Study Active

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Opthea Coast – Enrollment Closed, but Study Active

  • A multicenter, randomized, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.​

  • More information can be found here.

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Valo Health Spectra – Enrollment Closed, but Study Active

  • A Phase 2 randomized, double-masked, placebo controlled, multicenter study to evaluate the safety and efficacy of OPL-0401 oral pill in patients with non-proliferative diabetic retinopathy (NPDR). â€‹

  • More information can be found here.

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​​​If you would like to participate in our research program please contact our Research Coordinator, Jacque Smith, at (909) 335-8938 or email: jsmith@vrsurgeons.com.

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