Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04108156 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Diabetic Macular Edema, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 634
- Enrollment target
- 20
- Study locations
NCT04108156: Recruiting Phase 3 study of Diabetic Macular Edema, sponsored by Hoffmann-La Roche.
NCT04108156 is a Phase 3 study of Diabetic Macular Edema that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 634 participants, below the 3,784-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04108156, a Phase 3 study of Diabetic Macular Edema, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 634 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
Primary Outcome
BCVA = Best-Corrected Visual Acuity ETDRS = Early Treatment Diabetic Retinopathy Study A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
Conditions Studied
Interventions
- DRUG PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
- DRUG Intravitreal Ranibizumab 0.5 mg Injection
- DRUG Ranibizumab refill exchange
Study Locations (20)
California
- California Retina Consultants - Bakersfield
- Retina-Vitreous Associates Medical Group - Beverly Hills
- The Retina Partners - Encino
- Retina Consultants of Orange County;Clinical Research - Fullerton
- Jules Stein Eye Institute/ UCLA - Los Angeles
- Northern California Retina-Vitreous Associates - Mountain View
- East Bay Retina Consultants - Oakland
- Doheny Eye Institute - Pasadena
- California Eye Specialists Medical Group - Pasadena
- Retina Consultants Medical Group - Sacramento
- Zuckerberg San Francisco General Hospital and Trauma Center - San Francisco
- Orange County Retina Medical Group - Santa Ana
- California Retina Consultants;Research Department - Santa Barbara
Arizona
- Barnet Dulaney Perkins Eye Center - Mesa
- Retinal Consultants of Arizona;Opthalmology - Phoenix
- Arizona Retina and Vitreous Consultants - Phoenix
- Associated Retina Consultants - Phoenix
Colorado
- Eye Center of Northern Colorado - Fort Collins
- Colorado Clinical Research - Lakewood
Connecticut
- Retina Group of New England - Waterford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 634 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2027-11-16 |
| Phase | Phase 3 |
What NCT04108156 shows while recruiting
NCT04108156 is an interventional study that assigns participants to a tested intervention. The registered 634 participants enrollment target is mid-sized for trials with a published cap, below the 3,784-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 3 interventions - of which PDS Implant Pre-Filled with 100 mg/mL Ranibizumab is the first listed.
NCT04108156 names 20 study sites across 4 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT04108156 about?
NCT04108156 is a clinical study titled "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". This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting t...
What is the current status of trial NCT04108156?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 634 participants. The study started on 2019-09-30. Estimated completion is 2027-11-16.
What conditions does trial NCT04108156 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT04108156?
The interventions under investigation include: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab (DRUG), Intravitreal Ranibizumab 0.5 mg Injection (DRUG), Ranibizumab refill exchange (DRUG).
Who is sponsoring clinical trial NCT04108156?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04108156 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04108156's enrollment target sits among peer trials
634 6th of 63 higher than 58 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
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)
ACTIVE NOT RECRUITING · Phase 3
-
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
ACTIVE NOT RECRUITING · Phase 3
-
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
ACTIVE NOT RECRUITING · Phase 3
-
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573027 · 634 participants · NA
Heart Disease of the Small Arteries in Women and Men
- NCT07237295 · 634 participants · NA
CommunityRx-Kidney Health
- NCT03478826 · 635 participants
Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
- NCT03821129 · 636 participants · NA
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI