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ClinicalTrials.gov 10 recruiting now early-phase tilt

Diabetic Macular Edema: early-phase trial registry

10 of 64 indexed Diabetic Macular Edema trials are currently recruiting, with more weight in Phase 1-2.

Corpus placement: #215 of 28,707 conditions by registered trial count.

64 US clinical trials · 10 currently recruiting · #215 of 28,707 conditions by registered trial count

Diabetic Macular Edema: 64 US clinical trials tracked, 10 recruiting.

Diabetic Macular Edema is the subject of 64 registered US clinical trials on ClinicalTrials.gov, 10 of them currently open to new participants. 18 are in Phase 3-4 (later-stage) and 38 in Phase 1-2 (earlier-stage). The most active sponsor is Hoffmann-La Roche, running 5 of these trials.

Enrollment posture brief

Registry condition diabetic-macular-edema

OPEN 10 | RECR 16% | LATE 18 | EARLY 38 | RANK #215 | SPON 5

Nearest open-share peer: Bacterial Infections (16% recruiting · 19 trials)

Anatomic Stage I Breast Canc54.7%Congenital Heart Disease51.6%Pulmonary Arterial Hypertens32.8%Non-Hodgkin's Lymphoma18.8%Diabetic Macular Edema (this)16%
Open-enrollment share among volume-matched conditions near Diabetic Macular Edema

Diabetic Macular Edema lists 10 open slots (16% of 64 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for Diabetic Macular Edema on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. Diabetic Macular Edema is recruiting below its size-band peers.

    10 of 64 indexed trials (15.6%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. Sponsorship of Diabetic Macular Edema trials is spread across many organizations.

    Hoffmann-La Roche accounts for 5 of 64 trials (7.8%). 47 distinct sponsors appear on at least one study for this condition label.

  3. Typical Diabetic Macular Edema enrolment sits around 93 participants.

    Median target enrolment is 93 among the 64 trials that report a genuine target (sentinel values excluded). 33 of those (51.6%) plan for fewer than 100 participants.

  4. Diabetic Macular Edema research is mostly interventional.

    58 interventional and 6 observational studies make up this index (90.6% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 123Phase 215Phase 311Phase 47

Open and recent trials

64 total, page 1 of 2

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

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Phase Distribution

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

Named interventions

Most-linked intervention names on Diabetic Macular Edema records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

Faricimab Drug
6 trials
EYP-1901 Drug
3 trials
Aflibercept Drug
3 trials
Sham Procedure Other
3 trials
THR-149 dose level 3 Drug
2 trials
THR-149 dose level 2 Drug
2 trials
THR-149 dose level 1 Drug
2 trials
KVD001 Injection Drug
2 trials

US sites by state

Facility locations filed on Diabetic Macular Edema trials. A trial with sites in several states counts in each.

California 39 trials
Florida 25 trials
Arizona 25 trials
Texas 24 trials
Maryland 16 trials
Indiana 14 trials
Illinois 14 trials
Colorado 12 trials

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

What to do with this Diabetic Macular Edema page

64 registered trials, 10 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

  • 10 Diabetic Macular Edema trials are currently recruiting, check eligibility criteria before contacting a site. Browse recruiting trials
  • Hoffmann-La Roche sponsors the most Diabetic Macular Edema trials on record, review their full trial history before evaluating a specific study. See Hoffmann-La Roche's trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This Diabetic Macular Edema condition card totals 64 registered trials; most-linked intervention Faricimab; top US site state California. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.