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The purpose of this study was to assess the safety and tolerability of RO7200220 as monotherapy (diabetic macular edema [DME] or uveitic macular edema [UME] population) and in combination with ranibizumab (DME population only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: RO7200220 Monotherapy | Experimental | Participants with DME received multiple ascending doses of RO7200220 (two doses at the assigned dose level), as intravitreal (IVT) injection, every 6 weeks (Q6W) in multiple cohorts. |
|
| Part 2: Expansion of RO7200220 Monotherapy | Experimental | Participants with DME who were anti-VEGF and corticosteroid IVT treatment-naive received three doses of RO7200220 monotherapy, as IVT injection, every 4 weeks (Q4W) in Part 2 cohorts. |
|
| Part 3: RO7200220 in Combination with Ranibizumab | Experimental | Participants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3. |
|
| Part 4: RO7200220 Monotherapy | Experimental | Participants with UME received multiple doses of RO7200220 (three doses at the assigned dose level), as IVT injection, Q4W in multiple cohorts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7200220 | Drug | RO7200220 was administered as IVT injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Adverse Events (AEs) | Up to 18 weeks | |
| Part 2: Number of Participants With Adverse Events (AEs) | Up to 24 weeks | |
| Part 3: Number of Participants With Adverse Events (AEs) | Up to 20 weeks | |
| Part 4: Number of Participants With Adverse Events (AEs) | Up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) | Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36 | |
| Minimum Serum Concentration (Ctrough) | Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36 |
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Inclusion Criteria:
DME Participants:
UME Participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| California Retina Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41954903 | Derived | Sharma S, Lin P, Hu A, Suhler EB, Pauly-Evers M, Holmes W, Barekati Z, Willen D, Macgregor L, Steeples L, Haskova Z, Feenstra D, Silverman D, Passemard B, Fauser S, Mesquida M. Interleukin 6 Inhibition With Vamikibart for Uveitic Macular Edema: The Phase 1 DOVETAIL Nonrandomized Clinical Trial. JAMA Ophthalmol. 2026 May 1;144(5):442-451. doi: 10.1001/jamaophthalmol.2026.0610. |
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|
| Ranibizumab | Drug | Ranibizumab was administered as IVT injection. |
|
| Time to Peak Serum Concentration (Tmax) | Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36 |
| Area Under the Concentration-time Curve to the End of Dosing Period (AUC0-t) | Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36 |
| Oxnard |
| California |
| 93036 |
| United States |
| Retina Institute of California Medical Group d/b/a Acuity Eye Group | Palm Desert | California | 92260 | United States |
| Byers Eye Insitute at Stanford | Palo Alto | California | 94303 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Retina Vitreous Assoc of FL | St. Petersburg | Florida | 33711 | United States |
| Illinois Retina Associates SC | Oak Park | Illinois | 60304 | United States |
| Cumberland Valley Retina PC | Hagerstown | Maryland | 21740 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon HSU | Portland | Oregon | 97239 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Retina Res Institute of Texas | Abilene | Texas | 79606 | United States |
| Austin Clinical Research LLC | Austin | Texas | 78750 | United States |
| Valley Retina Institute P.A. | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Univ of Virginia Ophthalmology | Charlottesville | Virginia | 22903 | United States |
| Karalis Johnson Retina Center | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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