Clinical Trials

1) Acelyrin (non-infectious uveitis)

A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis

Status: Enrolling

PI: Quan Dong Nguyen, MD, MSc

Research Coordinators: Louis Jison, MD (ljison@stanford.edu), Negin Yavari, MD (nyavari@stanford.edu), Phone (650-724-8553)

For eligibility and more information, please see NCT05384249 (https://clinicaltrials.gov/study/NCT05384249?cond=Non-infectious%20Uveitis&intr=Izokibep&rank=1)

2) Atlas (Scleritis)

An Open Label, Multi-Centered, Randomized Phase 2 Study to Evaluate the Safety, Tolerability and Bioactivity of Subcutaneous ACTH GeL in PAtients with Scleritis: The ATLAS Study

Status: Enrolling

PI: Quan Dong Nguyen, MD, MSc

Research Coordinators: Louis Jison, MD (ljison@stanford.edu), Negin Yavari, MD (nyavari@stanford.edu), Phone (650-724-8553)

For eligibility and more information, please see NCT03465111 (https://clinicaltrials.gov/study/NCT03465111?cond=An%20Open%20Label,%20Multi-Centered,%20Randomized%20Phase%202%20Study%20to%20Evaluate%20the%20Safety,%20Tolerability%20and%20Bioactivity%20of%20Subcutaneous%20ACTH%20GeL%20in%20PAtients%20with%20Scleritis:%20The%20ATLAS%20Study&rank=1)

3) Dragon (Stargardt)

Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment of Stargardt Disease in Adolescent Subjects

Status: Active, closed for enrollment

PI: Loh-Shan Bryan Leung, MD

Research Coordinators: Louis Jison, MD (ljison@stanford.edu), Negin Yavari, MD (nyavari@stanford.edu), Phone (650-724-8553)

For eligibility and more information, please see NCT05244304 (https://clinicaltrials.gov/study/NCT05244304?cond=Phase%203,%20Multicenter,%20Randomized,%20Double-Masked,%20Placebo-Controlled%20Study%20to%20Evaluate%20the%20Safety%20and%20Efficacy%20of%20Tinlarebant%20in%20the%20Treatment%20of%20Stargardt%20Disease%20in%20Adolescent%20Subjects&rank=1)

4) Neptune (non-infectious uveitis)

A Phase 2 Randomized, Double-Masked, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Active Non-Infectious Intermediate-, Posterior-, and Panuveitis

Status: Active, closed for enrollment

PI: Quan Dong Nguyen, MD, MSc

Research Coordinators: Louis Jison, MD (ljison@stanford.edu), Negin Yavari, MD (nyavari@stanford.edu), Phone (650-724-8553)

For eligibility and more information, please see NCT05523765 (https://clinicaltrials.gov/study/NCT05523765?cond=A%20Phase%202%20Randomized,%20Double-Masked,%20Dose-Ranging%20Study%20to%20Investigate%20the%20Safety%20and%20Efficacy%20of%20Oral%20Brepocitinib%20in%20Adults%20with%20Active%20Non%20Infectious%20Intermediate-,%20Posterior-,%20and%20Panuveitis&rank=1)

5) BI 1386-0012 (Diabetic Retinopathy)

A randomized, double-masked, placebo-controlled exploratory study to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of orally administered BI 1467335 for 12weeks with a 12 week follow up period in patients with nonproliferative diabetic retinopathy without center-involved diabetic macular edema

A study that tests BI 1467335 in patients with diabetic eye disease (diabetic retinopathy). It looks at the way BI 1467335 is taken up, the effects it has, and how well it is tolerated..

Status: Enrolling

PI: Quan Dong Nguyen, MD, MSc

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see NCT (pending).

6) Gilead GS-US-432-4097 (Non-infectious uveitis)

A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non-Infectious Uveitis

The purpose of this study is to see if an alternative drug, called filgotinib is safe and effective in treating people with non-infectious uveitis. Filgotinib may work to block specific pathways that may be important to the type of eye inflammation that leads to uveitis. This study will examine whether filgotinib can effectively control this inflammation over time so flares of uveitis are avoided. This will happen as a standard steroid therapy is slowly discontinued.

Status: Enrolling

PI: Quan Dong Nguyen, MD, MSc

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see NCT03207815.

7) SAVE2 (Non-infectious uveitis)

Sirolimus as a Therapeutic Approach for UVEitis: A Phase 2, Open-label, Randomized Study to Assess the Safety, Tolerability, and Bioactivity of Two Doses of Intravitreal Injection of Sirolimus in Patients with Non-infectious Uveitis (the SAVE-2 Study)

The purpose of this study is to see if locally delivered sirolimus is a viable treatment of uveitis. The potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and yet avoid the potential complications that are usually associated with the systemic use of the drug and other immunomodulatory therapies.

Status: Enrolling

PI: Quan Dong Nguyen, MD, MSc

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see NCT01280669.

8) APL2-304 (Geographic Atrophy)

A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Status:

PI: Quan Dong Nguyen, MD, MSc

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

9) BP39601 (Diabetic Macular Edema)

A multi-center, non-randomized, open-label, multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7200220 following intravitreal administration in patients with diabetic macular edema

Status: In Development

PI: Quan Dong Nguyen, MD, MSc

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

10) Port Delivery System (Wet AMD)

A PHASE III, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED, ACTIVE-COMPARATOR STUDY OF THEEFFICACY, SAFETY, AND PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITHNEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Status: Enrollment opening soon

PI: Quan Dong Nguyen, MD, MSc

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

11) AKB-9778-CI-5001 (Non-Proliferative Diabetic Retinopathy)

Phase 2 Double-masked, Placebo-controlled Study To Assess 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

Status: Closing

PI: Diana Do, MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

12) Draw2 (Diabetic Macular Edema)

A pharmacokinetic stuDy of intRavtreal Aflibercept injection in vitrectomized and non-vitrectomized eyes With diabetic macular edema.

The primary objective is to investigate and characterize the amount of drug available following single or multiple injections of EYLEA® (Regeneron Pharmaceuticals, Inc.), in eyes with diabetic macular edema. The study looks at both subjects who have and have not had a surgery called a vitrectomy for their diabetic eye disease. Studies have focused on subjects who have not had vitrectomy, so little is known about the best dosing needed for subjects who have had this surgery.

Status: In Development

PI: Diana Do, MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see NCTPending.

13) OpRegen (Geographic Atrophy)

Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients With Advanced Dry-Form Age-Related Macular Degeneration (Geographic Atrophy)

The main objective of the study is evaluation of the safety and tolerability of OpRegen - human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.

Status: Enrolling

PI: Diana Do, MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see NCT02286089.

14) Aldeyra ADX-102-UV-005 (Non-infectious anterior uveitis)

A Phase 3 Randomized, Double-Masked, Vehicle-Controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects with Non-infectious Anterior Uveitis

The sponsor is developing ADX-102 ophthalmic solution. ADX-102 is an anti-inflammatory eye drop. The purpose of this study is to compare the effects of ADX-102 to placebo in treating the signs and symptoms of anterior uveitis in participants with non-infectious anterior uveitis. ADX-102 and placebo are given as eye drops.

Status: Enrolling

PI: Diana Do , MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see NCT03131154.

15) Topaz (Retinal Vein Oclusion)

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS - TA with Intravitreal Intravitreal Aflibercept in Subjects With Retinal Vein Occlusion

Status: Enrollment opening soon

PI: Diana Do , MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

16) LIGHTSITE II (Dry AMD)

A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects with Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE II)

Status: In Development

PI: Diana Do , MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

17) Sushi (Wet AMD)

Phase 1/2 Open label, Dose-escalation Study of the Safety and OcUlar Tolerability of a Single Intravitreal Injection of RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration (SUSHI)

Status: In Development

PI: Diana Do , MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

18) KALVISTA (ciDME)

A Randomized Sham-Controlled Double-Masked Phase 2a Study of the Efficacy, Safety and Tolerability of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-Involving Diabetic Macular Edema (ciDME) who Have had Prior Anti-Vascular Endothelial Growth Factor (VEGF) Treatment

Status: Enrolling

PI: Diana Do , MD

Research Coordinator: Louis (ljison@stanford.edu)

For eligibility and more information, please see

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