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
Public ClinicalTrials.gov record NCT06850922. 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/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06850922
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 388 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
- Jun 22, 2022 (Actual)
- Primary completion
- May 19, 2026 (Actual)
- Completion
- Jun 19, 2026 (Actual)
- Last update posted
- Jun 23, 2026
2022 – 2026
United States locations
- U.S. sites
- 70
- U.S. states
- 25
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Retina and Vitreous Consultants | Phoenix | Arizona | 85020-5917 | — |
| Associated Retinal Consultants PC | Phoenix | Arizona | 85020 | — |
| Retinal Research Institute, LLC | Phoenix | Arizona | 85053 | — |
| Retina Partners of Northwest Arkansas, PLLC | Springdale | Arkansas | 72764 | — |
| Retinal Diagnostic Center | Campbell | California | 95008 | — |
| Retina Consultants of Orange County | Fullerton | California | 92835 | — |
| Retinal Consultants Medical Group | Modesto | California | 95356-9412 | — |
| Northern California Retina-Vitreous Associates | Mountain View | California | 94040 | — |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| Macula Retina Vitreous Research Institute | Torrance | California | 90503-3270 | — |
| Bay Area Retina Associates;Study Department | Walnut Creek | California | 94598 | — |
| University of Colorado - Eye Center - PPDS | Aurora | Colorado | 80045-2517 | — |
| Retina Consultants of Southern Colorado PC | Colorado Springs | Colorado | 80909 | — |
| Retina Specialists of Colorado | Denver | Colorado | 80222 | — |
| Advanced Vision Research Institute | Longmont | Colorado | 80503-6499 | — |
| Retina Group of New England | Waterford | Connecticut | 06385-1215 | — |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | — |
| Florida Retina Institute | Jacksonville | Florida | 32216-6347 | — |
| Retina Associates of Florida;Retina Associates of Florida | Tampa | Florida | 33609 | — |
| Southeast Retina Center | Augusta | Georgia | 30909-6440 | — |
| Georgia Retina PC | Marietta | Georgia | 30060 | — |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | — |
| Illinois Eye and Ear Infirmary | Chicago | Illinois | 60612 | — |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | — |
| Raj K. Maturi, MD PC | Indianapolis | Indiana | 46290 | — |
| The Retina Care Center | Baltimore | Maryland | 21209 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| Chesapeake Retina Centers - Waldorf | Waldorf | Maryland | 20602 | — |
| Associated Retinal Consultants - Royal Oak | Royal Oak | Michigan | 48073 | — |
| Retina Consultants Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| Long Island Vitreoretinal Consultants;Opthalmology | Hauppauge | New York | 11788 | — |
| Retina Vitreous Surgeons of CNY PC | Liverpool | New York | 13088 | — |
| Opthalmic Consultants of LI | Lynbrook | New York | 11563 | — |
| Western Carolina Retinal Associate PA | Asheville | North Carolina | 28803 | — |
| North Carolina Retina Associates | Cary | North Carolina | 27511 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Graystone Eye-Hickory | Hickory | North Carolina | 28602 | — |
| North Carolina (NC) Retina Associates - Wake Forest Office | Wake Forest | North Carolina | 27587-3803 | — |
| Piedmont Retina Specialists | Winston-Salem | North Carolina | 27103-6970 | — |
| Cincinnati Eye Institute | Blue Ash | Ohio | 45242-5537 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44016 | — |
| Ohio State Eye and Ear Institute | Columbus | Ohio | 43212 | — |
| Tulsa Retina Consultants | Tulsa | Oklahoma | 74114 | — |
| Cascade Medical Research Institute LLC | Springfield | Oregon | 97477 | — |
| Erie Retina Research | Erie | Pennsylvania | 16505 | — |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107-5109 | — |
| Sewickely Eye Group | Sewickley | Pennsylvania | 15143 | — |
| Palmetto Retina Center | West Columbia | South Carolina | 29169-2429 | — |
| Charles Retina Institute | Germantown | Tennessee | 38138 | — |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | — |
| Texas Retina Associates | Arlington | Texas | 76012 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Austin Clinical Research LLC | Austin | Texas | 78750 | — |
| Retina & Vitreous of Texas | Bellaire | Texas | 77401 | — |
| Texas Retina Associates | Dallas | Texas | 75231 | — |
| Valley Retina Institute P.A. | McAllen | Texas | 78550-9207 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas - San Antonio | San Antonio | Texas | 78240 | — |
| Brown Retina Institute | San Antonio | Texas | 78251-4551 | — |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | — |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | — |
| Retina Associates of Utah, PLLC;Clinical Research | Salt Lake City | Utah | 84107 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502-4271 | — |
| Wagner Kapoor Institute | Norfolk | Virginia | 23502 | — |
| Virginia Eye Institute - Richmond - 7301 Forest Ave | Richmond | Virginia | 23230 | — |
| Retina Institute of Virginia | Richmond | Virginia | 23235-1962 | — |
| Spokane Eye Clinical Research | 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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06850922, 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 Jun 23, 2026 · Synced Oct 24, 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 NCT06850922 live on ClinicalTrials.gov.