A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
Public ClinicalTrials.gov record NCT06847854. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Multipart, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7497372 Following Intravitreal Administration in Participants With Diabetic Macular Edema (Part 1 Non-Randomized, Open-Label, Multiple Ascending Dose; Part 2 Randomized, Double-Masked)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06847854
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 151 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 8, 2022 (Actual)
- Primary completion
- Nov 16, 2026 (Estimated)
- Completion
- Jan 18, 2027 (Estimated)
- Last update posted
- Sep 2, 2026
2022 – 2027
United States locations
- U.S. sites
- 37
- U.S. states
- 20
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Mesa | Arizona | 85206 | — |
| Retinal Consultants of AZ, Ltd | Peoria | Arizona | 85381 | — |
| Associated Retina Consultants | Phoenix | Arizona | 85020 | — |
| Arkansas Retina Research | Little Rock | Arkansas | 72205 | — |
| Global Research Management | Glendale | California | 91204 | — |
| Retinal Consultants Medical Group | Modesto | California | 95356 | — |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | — |
| Florida Eye Associates | Melbourne | Florida | 32901 | — |
| Medeye Associates | South Miami | Florida | 33143 | — |
| East Florida Eye Institute | Stuart | Florida | 34994 | — |
| Retina Specialists of Tampa | Wesley Chapel | Florida | 33544 | — |
| Center for Retina and Macula Disease | Winter Haven | Florida | 33880 | — |
| Cumberland Valley Retina PC | Hagerstown | Maryland | 21740 | — |
| Retina Associates of Michigan | Grand Blanc | Michigan | 48439 | — |
| Foundation for Vision Research | Grand Rapids | Michigan | 49546 | — |
| Retina Consultants Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| Mississippi Retina Associates | Madison | Mississippi | 39202 | — |
| The Retina Institute | St Louis | Missouri | 63128 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| Ross Eye Institute | Buffalo | New York | 14209 | — |
| Retina Associates of NY | New York | New York | 10075 | — |
| Cleveland Clinic | Cleveland | Ohio | 44106 | — |
| Verum Research LLC | Eugene | Oregon | 97401 | — |
| EyeHealth Northwest | Portland | Oregon | 97225 | — |
| Erie Retinal Surgery | Erie | Pennsylvania | 16507 | — |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | — |
| Carolina Eyecare Physicians | Mt. Pleasant | South Carolina | 29464 | — |
| Charles Retina Institute | Germantown | Tennessee | 38138 | — |
| Austin Clinical Research LLC | Austin | Texas | 78750 | — |
| Brown Retina Institute | Schertz | Texas | 78154 | — |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | — |
| Salt Lake Retina | West Jordan | Utah | 84088 | — |
| Retina Group of Washington | Fairfax | Virginia | 20815 | — |
| Emerson Clinical Research Institute | Falls Church | Virginia | 78503 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Wagner Kapoor Institute | Norfolk | Virginia | 23502 | — |
| Spokane Eye Clinic | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06847854, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06847854 live on ClinicalTrials.gov.