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2026 data Public-data reference. official source

Diabetic Macular Edema

Open-data reference.

64 US clinical trials · 10 currently recruiting

Active & Recent Trials

RECRUITING Phase 3 634 participants

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME

Hoffmann-La Roche

NCT04108156

RECRUITING Phase 1 546 participants

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema

Genentech

NCT06850922

RECRUITING Phase 3 240 participants

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

EyePoint Pharmaceuticals

NCT07449923

RECRUITING Phase 3 240 participants

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

EyePoint Pharmaceuticals

NCT07449936

RECRUITING Phase 1 93 participants

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)

Genentech

NCT07425522

RECRUITING Phase 1 75 participants

EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema

Eclipse Life Sciences

NCT06536491

RECRUITING Phase 1 24 participants

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

Ocugen

NCT05802329

RECRUITING Phase 2 18 participants

Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)

Sierra Eye Associates

NCT06942520

RECRUITING Phase 1 10 participants

Kamuvudine-9 (K9) in Diabetic Macular Edema

Dr. Bryan Strelow

NCT07458061

RECRUITING Phase 1 5 participants

Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)

Michelle Abou-Jaoude

NCT06781255

ACTIVE NOT RECRUITING 6,000 participants

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

Hoffmann-La Roche

NCT05476926

ACTIVE NOT RECRUITING Phase 3 1,118 participants

A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Regeneron Pharmaceuticals

NCT06491914

ACTIVE NOT RECRUITING Phase 2 552 participants

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

Oculis

NCT05066997

ACTIVE NOT RECRUITING Phase 4 446 participants

Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

McMaster University

NCT05610319

ACTIVE NOT RECRUITING Phase 3 401 participants

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

Oculis

NCT06172257

ACTIVE NOT RECRUITING Phase 4 300 participants

A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

Alimera Sciences

NCT04469595

ACTIVE NOT RECRUITING 300 participants

Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images

Charles Drew University of Medicine and Science

NCT03694145

ACTIVE NOT RECRUITING Phase 4 218 participants

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

Genentech

NCT05224102

ACTIVE NOT RECRUITING Phase 1 151 participants

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

Genentech

NCT06847854

ACTIVE NOT RECRUITING Phase 2 128 participants

Evaluation of Tonabersat for DME

Jaeb Center for Health Research

NCT05727891

ACTIVE NOT RECRUITING Phase 3 120 participants

A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

Outlook Therapeutics

NCT05112861

ACTIVE NOT RECRUITING Phase 2 72 participants

4D-150 in Patients With Diabetic Macular Edema

4D Molecular Therapeutics

NCT05930561

ACTIVE NOT RECRUITING Phase 2 50 participants

Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME

Ashvattha Therapeutics

NCT05387837

ACTIVE NOT RECRUITING 22 participants

Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)

Adverum Biotechnologies

NCT05607810

ACTIVE NOT RECRUITING Phase 1 19 participants

Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

AiViva BioPharma

NCT05698329

COMPLETED 221,004 participants

Describing Patient With DME, Their Patient Journey and Disease Progression

Boehringer Ingelheim

NCT05966753

COMPLETED Phase 3 1,479 participants

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Hoffmann-La Roche

NCT04432831

COMPLETED 942 participants

Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

Eyenuk

NCT03112005

COMPLETED Phase 3 566 participants

Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Novartis Pharmaceuticals

NCT03481634

COMPLETED Phase 3 399 participants

Anti-VEGF Treatment for Prevention of PDR/DME

Jaeb Center for Health Research

NCT02634333

COMPLETED Phase 2 302 participants

Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema

Regeneron Pharmaceuticals

NCT02712008

COMPLETED 287 participants

NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

Notal Vision

NCT03969303

COMPLETED Phase 2 267 participants

Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

Fovea Pharmaceuticals

NCT01319487

COMPLETED Phase 2 258 participants

PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)

Quark Pharmaceuticals

NCT01445899

COMPLETED Phase 3 195 participants

A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

Outlook Therapeutics

NCT04516278

COMPLETED Phase 2 187 participants

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

Hoffmann-La Roche

NCT05151744

COMPLETED Phase 1 153 participants

A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

Opthea Limited

NCT03397264

COMPLETED Phase 1 150 participants

A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema

Palmetto Retina Center

NCT01934556

COMPLETED Phase 2 135 participants

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

Oxurion

NCT04527107

COMPLETED Phase 2 129 participants

Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)

KalVista Pharmaceuticals

NCT03466099

COMPLETED Phase 2 125 participants

NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)

Jaeb Center for Health Research

NCT01331005

COMPLETED Phase 1 81 participants

First-In-Human Study of CU06-1004 Following Single and Multiple Ascending Doses in Healthy Volunteers

Curacle Co.

NCT04795037

COMPLETED NA 50 participants

30g vs 33g Needle for Intravitreal Injections

Wills Eye

NCT03038048

COMPLETED Phase 2 49 participants

Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Rocky Mountain Retina Consultants

NCT00387582

COMPLETED Phase 1 44 participants

Safety and Exploratory Efficacy Study of SF0166 for the Treatment of Diabetic Macular Edema (DME)

OcuTerra Therapeutics

NCT02914613

COMPLETED Phase 4 40 participants

Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab

California Retina Consultants

NCT02107131

COMPLETED Phase 1 40 participants

Cooling Anesthesia for Intravitreal Injection

Recens Medical

NCT03732287

COMPLETED NA 36 participants

Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

Mayo Clinic

NCT02951351

COMPLETED Phase 3 35 participants

A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe

Hoffmann-La Roche

NCT05569148

COMPLETED Phase 1 31 participants

Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema

SurModics

NCT00915837

COMPLETED Phase 4 30 participants

Ocular Safety and Usability Study for FYB203 PFS

Formycon

NCT06708637

COMPLETED Phase 4 30 participants

IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab

Southeast Retina Center, Georgia

NCT03340610

COMPLETED Phase 1 29 participants

Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE)

David M. Brown, M.D.

NCT01552408

COMPLETED Phase 2 27 participants

Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)

EyePoint Pharmaceuticals

NCT06099184

COMPLETED Phase 2 25 participants

Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Oxular Limited

NCT05512962

COMPLETED Phase 1 25 participants

The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates

South Coast Retina Center; Carson, McBeath, Boswell

NCT02448446

COMPLETED Phase 1 21 participants

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients

Novartis Pharmaceuticals

NCT04635800

COMPLETED Phase 1 20 participants

Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Santen SAS

NCT00665106

COMPLETED Phase 1 20 participants

Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema

Clearside Biomedical

NCT02949024

COMPLETED Phase 1 14 participants

A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME

KalVista Pharmaceuticals

NCT02193113

COMPLETED Phase 1 12 participants

A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)

ThromboGenics

NCT03666923

COMPLETED Phase 1 12 participants

A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)

ThromboGenics

NCT03511898

COMPLETED Phase 4 10 participants

Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis

Vitreo-Retinal Associates, Michigan

NCT03097068

COMPLETED Phase 1 4 participants

Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study

Medical College of Wisconsin

NCT00846092

Phase Distribution

PhaseTrial count
Early Phase 1 23
Phase 2 15
Phase 3 11
Phase 4 7

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Diabetic Macular Edema Trial Landscape

ClinicalTrials.gov lists 64 US studies indexed under Diabetic Macular Edema, and 10 of those are currently open to recruitment — roughly 16% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Diabetic Macular Edema shows 18 late-stage studies (Phase 3 and Phase 4 combined) alongside 38 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Diabetic Macular Edema is led by Hoffmann-La Roche with 5 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 64 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Diabetic Macular Edema?

PlainTrial tracks 64 US clinical trials for Diabetic Macular Edema, of which 10 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Diabetic Macular Edema?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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