Astellas Reveal -  Actively Enrolling 

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• A non-interventional, observational study to evaluate treatment patterns and safety of Avacincaptad pegol (ACP/IZERVAY) in routine clinical practice in patients with geographic atrophy secondary to age related macular degeneration. 

  • ​Sponsor: Astellas Pharm.

  • Length of Study: 3 to 5 years (Observational study)

  • Treatment: Izervay, for GA secondary to AMD

  • Must be treatment-naïve to Izervay

  • 90-day washout period if previously treated with Syfovre

  • Key exclusions:

    • Active ocular or peri-ocular infections

    • Intraocular inflammation

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• More information can be found here.​

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Consent form available here to print. (Last updated August 13, 2024)

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​​​EyePoint Lugano - Actively Enrolling for Treatment-Naïve Patients

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• A randomized, double-masked, multicenter, phase 3 study evaluating EYP-1901 (tyrosine-kinase inhibitor) vs Eylea 2 mg in treatment-naïve 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-naïve patients with wet AMD​

  • 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

  • PED < 400 µm

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

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• More information can be found here.

 

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

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​​​​EyeBio Brunello/Barolo - Actively Enrolling

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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), extended interval for Barolo study

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

  • Treatment-naïve (still enrolling) and treatment-experienced (now closed as of 3/14/25) 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 naïve, 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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• More information can be found here.

 

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. ​

  • 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 -> only a couple of spots remaining!!

• 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: 36 months + 24 months 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 x6 months

  • Approved IOLs:

    • Alcon = SN60WF, SA60WF, SN60AT, ZA9003, ZCB00, CC60WF, CCA0T0, SY60WF, CNA0T

    • Carl Zeiss = CT Lucia (602)

    • J&J = ZA9003 (Tecnis), ZCB00 (PCB00/DCB00)

  • BCVA 20/80 - 20/400 in surgery eye (non-dominant eye).

  • FE BCVA 20/63 or worse.

  • Stable Glaucoma (POAG) is acceptable.

  • No history of RD.

  • Low vision evaluation is needed before consent.

• More information can be found here.

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Oculis DX219, Diamond - Enrollment Closed, but Study Active

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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). ​​

  • Length of Study: 52 Weeks (12 visits)

  • Treatment: OCS-01 Eye Drops vs. Placebo

• More information can be found here.

 

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Regeneron Elara - Enrollment Closed, but Study Active

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• A phase 3B single-arm study of aflibercept 8 mg in participants with neovascular age related macular degeneration (nAMD) or diabetic macular edema (DME).

  • ​Sponsor: Regeneron

  • Length of Study: 96 Weeks (2 years)

  • Treatment: Aflibercept 8mg (Open Label)​

• More information can be found here.

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Kodiak Sciences Inc, GLOW2 – Enrollment Closed, but Study Active

• 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-naïve Moderately Severe to Severe NPDR (DRSS 47-53)

  • ​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. ​​

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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

• 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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