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NCT06847854 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
A Phase 1 study of Diabetic Macular Edema, sponsored by Genentech.
- Active
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT06847854: Active Phase 1 study of Diabetic Macular Edema, sponsored by Genentech.
NCT06847854 is a Phase 1 study of Diabetic Macular Edema that is active but no longer recruiting, run by Genentech. The registered enrollment target is 151 participants, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06847854, a Phase 1 study of Diabetic Macular Edema, is active but no longer recruiting, sponsored by Genentech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.
Conditions Studied
Interventions
- DRUG RO7497372
Study Locations (20)
Florida
- Florida Eye Associates - Melbourne
- Medeye Associates - Miami
- East Florida Eye Institute - Stuart
- Retina Specialists of Tampa - Wesley Chapel
- Center for Retina and Macula Disease - Winter Haven
Arizona
- Barnet Dulaney Perkins Eye Center - Mesa
- Retinal Consultants of AZ, Ltd - Peoria
- Associated Retina Consultants - Phoenix
California
- Global Research Management - Glendale
- Retinal Consultants Medical Group - Modesto
- Bay Area Retina Associates - Walnut Creek
Michigan
- Retina Associates of Michigan - Grand Blanc
- Foundation for Vision Research - Grand Rapids
Arkansas
- Arkansas Retina Research - Little Rock
Maryland
- Cumberland Valley Retina PC - Hagerstown
Minnesota
- Retina Consultants Minnesota - Saint Louis Park
Mississippi
- Mississippi Retina Associates - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2022-12-08 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What the registry record for NCT06847854 still lists
NCT06847854 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which RO7497372 is the first listed.
NCT06847854 names 20 study sites across 11 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT06847854 about?
NCT06847854 is a clinical study titled "A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)". This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data f...
What is the current status of trial NCT06847854?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2022-12-08. Estimated completion is 2027-04-30.
What conditions does trial NCT06847854 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT06847854?
The interventions under investigation include: RO7497372 (DRUG).
Who is sponsoring clinical trial NCT06847854?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06847854 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06847854's enrollment target sits among peer trials
151 25th of 63 higher than 39 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.
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