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NCT06850922 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Diabetic Macular Edema, sponsored by Genentech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 546
- Enrollment target
- 20
- Study locations
NCT06850922 is a Phase 1 study of Diabetic Macular Edema that is actively recruiting participants, run by Genentech. The registered enrollment target is 546 participants, below the 3,786-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT06850922, a Phase 1 study of Diabetic Macular Edema, is actively recruiting participants, sponsored by Genentech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 546 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
Conditions Studied
Interventions
- DRUG Faricimab
- DRUG Aflibercept
- DRUG RO7446603
Study Locations (20)
California
- Retinal Diagnostic Center - Campbell
- The Retina Partners - Encino
- Retina Consultants of Orange County - Fullerton
- Retinal Consultants Medical Group - Modesto
- Northern California Retina-Vitreous Associates - Mountain View
- Retinal Consultants Medical Group - Sacramento
- University of California San Francisco - San Francisco
- Macula Retina Vitreous Research Institute - Torrance
- Bay Area Retina Associates;Study Department - Walnut Creek
Arizona
- Barnet Dulaney Perkins Eye Center - Phoenix
- Arizona Retina and Vitreous Consultants - Phoenix
- Associated Retinal Consultants PC - Phoenix
- Retinal Research Institute, LLC - Phoenix
Colorado
- University of Colorado - Eye Center - PPDS - Aurora
- Retina Consultants of Southern Colorado PC - Colorado Springs
- Retina Specialists of Colorado - Denver
- Advanced Vision Research Institute - Longmont
Florida
- Blue Ocean Clinical Research - Clearwater
- National Ophthalmic Research Institute - Fort Myers
Connecticut
- Retina Group of New England - Waterford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06850922
The ClinicalTrials.gov registry entry for NCT06850922 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,786-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (86% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 3 interventions - of which Faricimab is the first listed.
NCT06850922 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT06850922 about?
NCT06850922 is a clinical study titled "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". This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multi...
What is the current status of trial NCT06850922?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 546 participants. The study started on 2022-06-22. Estimated completion is 2027-04-30.
What conditions does trial NCT06850922 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT06850922?
The interventions under investigation include: Faricimab (DRUG), Aflibercept (DRUG), RO7446603 (DRUG).
Who is sponsoring clinical trial NCT06850922?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06850922 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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