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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​​​​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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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). ​

  • 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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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. ​

  • 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. ​(Last updated July 17, 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.​

  • Sponsor: Roche

  • Length of Study: 52 Weeks (15 visits) 

  • Treatment: RO7200220 (0.25mg or 1.0mg) vs. Sham

  • Diagnosis of active/inactive, or chronic non-infectious uveitis (NIU) of any etiology or anatomical type 

  • Macular edema associated with NIU (CST of  ≥ 315 um)

  • Study Eye BCVA 20/40 - 20/400 (73-19 letters) 

  • Non-Study eye BCVA 20/320 or better 

  • Study Eye

    • No prior macular focal/grid/micropulse laser

    • No prior PRP (in last 3 months)

    • No prior anti-VEGF therapies (in last 2 months) 

    • No Ozurdex (in last 4 months)

    • No prior PPV

• More information can be found here.

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

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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. ​

  • Sponsor: Formycon AG

  • Length of Study: 2 office visits + 1 follow up call 

  • Treatment: 2 mg FYB203 (aflibercept) PFS

  • Exclusions:

    • Previous treatment with any other anti-VEGF in the past 3 months ​(must be getting Eylea)

    • Intraocular corticosteroids in the SE within 30 days of Day 1

    • History of Covid-19 in the last month prior to screening 

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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).​

  • Sponsor: Jansen & Johnson

  • Length of Study: 2 Years (13 visits)

  • Treatment: Gene Therapy JNJ-81201887 vs. Placebo 

  • Foveal sparing GA size: 1-7 DA

  • Syfovre in Fellow eye is okay but needs to be stopped 15 days prior to Day 1 (Randomization)

• More information can be found here.

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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

• A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration​

• More information can be found here.

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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). ​

• 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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