Ocular Therapeutic HELIOS-3 (OTX-TKI-2025-NPDR-302)  - Actively Enrolling (NEW!)

​​​​

• A randomized, double-masked, multicenter Phase 3 study evaluating AXPAXLI™ (OTX-TKI; 0.45 mg axitinib implant) in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME). 

• Sponsor: Ocular Therapeutix

• Study treatment: Participants are randomized 1:1 to receive either OTX-TKI by intravitreal injection on Day 1 and Week 48, or a sham procedure at the same time points.

• OTX-TKI / AXPAXLI: A long-acting, bioresorbable hydrogel implant containing axitinib, a tyrosine kinase inhibitor. 

• Purpose: To evaluate whether OTX-TKI can improve or stabilize diabetic retinopathy severity and reduce progression to complications such as center-involved DME, proliferative diabetic retinopathy, or anterior segment neovascularization. 

• Study duration: 2 years. Visits q4 weeks through Week 56 and q8 weeks thereafter through Week 96. 

• Key Inclusion Criteria:

  • Moderately severe to severe NPDR (DRSS 47 or 53)

  • Vision approximately 20/40 or better in the study eye

  • Diabetes medications stable for at least 3 months

• Key Exclusion Criteria:

  • Center-involved DME with CMT ≥325 µm

  • Prior PRP laser in the study eye

  • Anti-VEGF injection in the study eye within the previous 6 months

  • Prior vitrectomy or scleral buckle

  • Recent cataract or other anterior-segment surgery within 3 months

  • Uncontrolled glaucoma with IOP ≥25 mmHg despite treatment

  • HbA1c >12% or kidney dialysis

  • Starting a GLP-1 medication or insulin within 3 months of screening.

• More information can be found here.

• Consent form available here to print (Last updated October 12, 2026).

 

 

​Apellis GALLOP (APL3007-GA-201) - Actively Enrolling (NEW!)

​​​​

• A randomized, masked, placebo-controlled, multicenter Phase 2 study evaluating APL-3007 (subcutaneous injection) in combination with Syfovre (pegcetacoplan) in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration.

• Sponsor: Apellis Pharmaceuticals

• Study treatment: Syfovre combined with either subcutaneous APL-3007 or subcutaneous placebo.

• Purpose: To evaluate whether adding APL-3007 to Syfovre may provide greater suppression of complement activity and slow the progression of GA compared with Syfovre alone.

• APL-3007: An investigational siRNA therapy designed to reduce the liver’s production of complement C3.

• Key Inclusion Criteria:

  • Age 60 years or older

  • Geographic atrophy secondary to AMD

  • Vision 20/100 or better in the study eye

  • Non-subfoveal GA (GA has not yet reached the center of the fovea)

  • Total GA area 2.5–17.5 mm² (1–7 disc areas)

  • If multifocal, at least one individual GA lesion must be ≥1.25 mm²

  • Prior Syfovre treatment is allowed

• Key Exclusion Criteria:

  • History or evidence of wet AMD/choroidal neovascularization in the study eye

  • Intravitreal injection within 3 months of screening, except Syfovre

  • GA caused by a condition other than AMD

  • Significant liver disease or certain abnormal liver-function tests

  • Certain uncontrolled systemic medical conditions or active/recent infections

  • Pneumococcal and meningococcal vaccination is required before treatment for participants who are not already appropriately vaccinated.

  • More information can be found here.

  • Consent form available here (English) to print. (Last updated September 11, 2026)

​​

​​​​​​​​​​​​​​​​Merck EyeBiotech MALBEC - Actively Enrolling (NEW!)

​​​​

• A randomized, double-masked, multicenter, three-arm, pivotal Phase 2/3 study evaluating the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration.

  • MALBEC = Macular Angiogenesis and Leakage Blockade via Endothelial Cell stabilization

  • ​Sponsor: Merck EyeBiotech

  • Who: Patients with new wet ARMD with edema in central fovea area on OCT.

    • No minimum OCT thickness

    • Visual acuity in study eye: 20/32 to 20/320 

    • Non-study eye: 38 letters or better (around 20/160-20/200)

    • Must be screened within 28 days of diagnosis.

  • What: comparison of an anti-body with anti TIE-2 and anti VEGF (2 dosages) versus Eylea in 1:1:1 randomization.

  • How: 3 monthly loading dosages of IV medication then q8 weeks for each group with rescue treatment criteria.

  • Exclusion:

    • Prior cataract surgery within 90 days of screening​

• Consent form available here in English, and here in Spanish to print. (Last updated June 5, 2026)

​​

​​

AbbVie ACHIEVE (ABB-RGX-314) - Actively Enrolling

​​​​

• A randomized controlled, partially masked, phase 3B study to assess the injection burden, efficacy, safety, and long-term preservation of visual acuity of surabgene lamparvovec (ABBV-RGX-314) in a real world context in subjects with neovascular age-related macular degeneration (nAMD). 

  • ​Sponsor: AbbVie

  • Participants will be placed into 1 of 3 treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled.

  • Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.

    • Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314.

    • Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection, and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection.

  • Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week-2 and lasts up to 5 years.

  • Inclusion Criterion:

    • Vision: 20/32 to 20/160 in the study eye; 20/200 or better in the non-study eye.​

  • Exclusion Criterion:

    • Foveal fibrosis or atrophy​

    • Lesion greater than 10 disc areas

    • RPE detachment >400 microns or RPE detachment >350 microns within the central subfield

    • Fluid within the parafovea at site visit 1

    • OCT improvement in fluid at site visit 2

• Public meeting minutes can be found here. (Last updated June 11, 2026)

• More information can be found here.

• Consent form available here in English or here in Spanish to print. (Last updated June 5, 2026)

​

 

​Kodiak PEAK - Actively Enrolling (PINNACLE enrollment closed)

​​​

• A randomized, double-masked, multicenter, phase 3 study evaluating the efficacy and safety of KSI-101 in patients with macular edema secondary to inflammation (MESI).

  • ​Sponsor: Kodiak 

  • Study treatment: KSI-101 (intravitreal biologic anti-IL6 and anti-VEGF trap)

    • 6 monthly doses followed by PRN treatment​

  • Sample size: 150 patients randomized (50 per arm, 5 mg vs 10 mg vs sham)

    • Rescue available for sham group if ≥15 letters and ≥CMT 100 microns from Day 1

  • Study duration: 52 weeks; 15 study visits

  • Inclusion Criterion: 

    • CMT ≥ 400 microns for PEAK (fyi, was 320 microns for PINNACLE)

    • BCVA ~20/25 to 20/320

    • Edema secondary to inflammation/uveitic macular edema, post-procedural edema (after cataract/retina/glaucoma surgery), inflammatory CNVM. 

    • Note, no limit to pressure-lowering IOP drops; however, cannot have uncontrolled glaucoma (IOP>24).

  • Exclusion Criterion:​

    • Macular edema secondary to DM, RVO, or wet AMD.​

    • Topical steroids more than 3 times per day within 2 weeks of Day 1 visit

    • Ozurdex within 3 months

    • Anti-VEGF within 2 months

    • PPV or CEIOL within 4 months

      • Past macula-involving retinal detachment or silicone oil tamponade is not allowed​

    • Glaucoma surgery (laser, MIGS, tubes, trabs), within 8 weeks (2 months)

    • Participation in prior Sandcat uveitis study for study eye

• More information can be found here.

• Consent form available here in English or here in Spanish to print. (Last updated June 5, 2026)​

​​​​

 

Kalaris Therapeutics KLRS-100 - Actively Enrollment, Treatment-Naive Arm Only

​​​

• A randomized, double-masked, multicenter, phase 1/2 study evaluating the efficacy and safety of TH103 in patients with treatment-naive (only) wet age-related macular degeneration.

  • ​Sponsor: Kalaris Therapeutics

  • Study treatment: TH103 (intravitreal anti-VEGF trap)​

  • Sample size: 30 patients randomized (5 doses, each group 3-6 patients)

    • Rescue available for sham group if ≥15 letters and ≥CMT 100 microns from Day 1

  • Study duration: 52 weeks; 15 study visits

  • Inclusion Criterion: 

    • CMT ≥ 325 microns

    • BCVA ~20/32 to 20/200 (note: must have 20/200 vision or better in contralateral eye)

      • Vision must be better than 20/200 prior to screening​

    • The treatment-experienced group is not currently recruiting for patients - previously, the diagnosis must be within 6 months, with no washout period. 

• More information can be found here.

• Consent form available: Part 1B (English); Part 1B (Spanish) to print. (Last updated June 5, 2026)​

​

​

​

AI Optics SPECTRA - Enrollment Closed  (Phase 2 pending)

​​​​

• A one-time prospective, multi-center, observation study for retinal data capature and targeted retinal analysis.

  • Non-mydriatic (undilated) non-interventional fundus photo study... ideally looking for diabetics with moderate to severe NPDR.

  • Prior intravitreal injections OK.

  • Prior laser (focal or PRP) in either eye is exclusionary. ​

  • Concurrent retinal vein occlusions (BRVO/CRVO) is an exclusion

  • Sponsor does not provide transportation.

  • More information can be found here: https://www.aioptics.ai/

  • Consent form available here (English) to print. (Last updated July 27, 2026)

​

​

Astellas Reveal - Enrollment Closed, but Study Active 

​​​

• 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

  • Prior Syfovre is OK, but 90-day washout period if previously treated with Syfovre​

• More information can be found here.​

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

 

​

Adverum Biotechnologies (ADVM-022-13) Aquarius - Enrollment Closed, but Study Active

​​​

• A clinical study evaluating ADVM-022, an investigational intravitreal gene therapy designed to provide long-term treatment for neovascular (wet) age-related macular degeneration.

  • Sponsor: Adverum Biotechnologies

  • Study treatment: Single intravitreal injection of ADVM-022 gene therapy ("biofactory") designed to enable the eye to continuously produce an anti-VEGF protein (similar to aflibercept)

  • Purpose: Evaluate whether a one-time gene therapy treatment can reduce or eliminate the need for frequent anti-VEGF injections

  • Study duration: ~2 years of follow-up

  • Inclusion criteria:

    • Age over 50

    • Vision 20/32 to 20/200 in the study eye

    • Vision 20/200 or better in the non study eye

    • Treatment-naive or treatment-experienced patients!!!

      • Prior anti-VEGF injection could be no sooner than 28 days prior to screening visit 1​

    • Must have demonstrated an anatomic response to anti-VEGF treatment

  • Exclusion criteria:

    • Prior intraocular or refractive surgery within 5 months​

  • ​Early studies showed up to ~81–94% reduction in annual injection frequency

• More information can be found here.

• A copy of the IBC meeting minutes can be found here.

• Consent form available here (English) or here (Spanish) to print. (Last updated June 5, 2026)

​

​

EyePoint CAPRI (EYP-1091) - Enrollment Closed, but Study Active

​​​​

• A randomized, double-masked, multicenter, Phase 3 study evaluating DURAVYU™ (EYP-1901, vorolanib) for patients with diabetic macular edema (DME).

  • ​Sponsor: EyePoint Pharmaceuticals

  • Study treatment: DURAVYU™ (EYP-1901, tyrosine kinase inhibitor) sustained-release intravitreal insert vs. aflibercept injections

  • Purpose: Evaluate whether a long-acting therapy that slowly releases medication over several months can reduce treatment burden while maintaining vision and retinal stability

  • Study duration: ~88 weeks

  • Inclusion Criterion: 

    • CMT ≥ 325 microns

    • BCVA ~20/32 to 20/200

      • Note, non study (contralateral) eye, must be better than 20/250​

    • A1C less than 10

  • Exclusion Criterion:​

    • Prior steroid injection​

    • Prior PPV

    • Any anti-VEGF within 3 months (for the treatment-experienced group - now closed as of 5/13/26) - only treatment-naive patients are allowed.

    • Any prior laser (focal or PRP) within 3 months

• More information can be found here.

• Consent form available here in English or here in Spanish to print. (Last updated June 5, 2026)

​​​​​​​​​​​​​​

OnPoint Vision – Phase 1 Enrollment Closed

• 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

  • Must be pseudophakic in both eyes.

  • 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).

• More information can be found here.

 

 

EyeBio Barolo/Brunello - Enrollment Closed, but Study Active

​​​​

• 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​​

• More information can be found here.

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

​

 

Adverum Artemis - Enrollment Closed, but Study Active

​​​

• A randomized, double-masked, multicenter, phase 3 study evaluating the efficacy and safety of Ixoberogene soroparvovec (Ixo-vec), compared to Eylea 2 mg q8 weeks, in patients with treatment-naïve wet age-related macular degeneration.

  • ​Sponsor: Adverum 

  • Sample size: 284 patients randomized (142 per arm) at 80 centers in the US

  • Length of Study: 8-week screening period, 56-week disease assessment period, and additional four year long-term follow-up period

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

• More information can be found here.

• Consent form available here to print. (Last updated June 30, 2025)​

 

 

EyePoint Lugano/Lucia - Enrollment Closed

​​​​

• 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​

• More information can be found here.

 

​Kyowa Kirin - Enrollment Closed

• 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)

• More information can be found here.

​​​​

Oculis DX219, Diamond - Enrollment Closed

​​

• 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.​

​​​

Regeneron Elara - Enrollment Closed

​​​​

• 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.​

 

Kodiak Sciences Inc, GLOW2 – Enrollment Closed

• 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.

​​​​​

​​​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.

​​

​​