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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Multiple Ascending Dose | Experimental | Participants will receive multiple ascending doses of RO7497372, 3 times every 4 weeks (Q4W) as an IVT injection up to Week 8 in the study eye. |
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| Part 2: RO7497372 Low Dose | Experimental | Participants will receive 6 doses of RO7497372, low dose, Q4W followed by 3 doses, every eight weeks (Q8W) as an IVT injection up to Week 44 in the study eye. |
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| Part 2: RO7497372 High Dose | Experimental | Participants will receive 6 doses of RO7497372, high dose, Q4W followed by 3 doses, Q8W as an IVT injection up to Week 44 in the study eye. Treatment in this arm has been discontinued due to the Sponsor's decision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7497372 | Drug | RO7497372 will be administered as IVT injection as per the schedule specified in the arms. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Adverse Events (AEs) | Up to 28 Weeks | |
| Part 2: Number of Participants With Intraocular Inflammation (IOI) AEs as Reported by the Investigator | Baseline to Week 48 | |
| Part 2: Number of Participants With Severe or Serious Drug-Related IOI AEs | Number of participants with severe or serious drug-related IOI AEs severity will be determined according to the DAIDS toxicity grading scale as reported by the Investigator. | Baseline to Week 48 |
| Part 2: Number of Participants With Occlusive Retinal Vasculitis AEs as Reported by the Investigator | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Concentration of RO7497372 in Blood | Up to Week 28 | |
| Part 1: Concentration of RO7497372 in Aqueous Humor (AH) | Up to Week 28 | |
| Part 2: Number of Participants With AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Mesa | Arizona | 85206 | United States | ||
| Retinal Consultants of AZ, Ltd |
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Part 1 is Sequential Assignment. Part 2 is Parallel Assignment.
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Number of participants with AEs severity determined according to the DAIDS toxicity grading scale. |
| Up to 56 weeks |
| Part 2: Number of Participants With Persistent Treatment-induced Anti-drug Antibody (ADAs) | Up to 56 weeks |
| Part 2: Concentration of RO7497372 in AH | Up to Week 56 |
| Part 2: Concentration of RO7497372 in Plasma | Up to Week 56 |
| Part 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time | BCVA will be measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA. | From Baseline (Day 1) up to Week 56 |
| Part 2: Absolute Value of BCVA Score Over Time | BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA. | Up to Week 56 |
| Part 2: Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time | BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA. | Up to Week 56 |
| Part 2: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time | BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA. | Up to Week 56 |
| Part 2: Change From Baseline in Central Subfield Thickness (CST) Over Time | CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by CRC evaluation of SD-OCT images. | From Baseline (Day 1) up to Week 56 |
| Part 2: Absolute Value of CST Over Time | CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by CRC evaluation of SD-OCT images. | Up to Week 56 |
| Part 2: Percentage of Participants With Absence of DME Over Time | Absence of DME is defined as CST < 325 micrometre (μm) by spectral domain optical coherence tomography (SD-OCT). | Up to Week 56 |
| Part 2: Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time | Presence of intraretinal and subretinal fluid will be determined by CRC evaluation of SD -OCT images. | Up to Week 56 |
| Part 2: Percentage of Participants With ≥ 2-step Diabetic Retinopathy Severity Scale (DRSS) Improvement From Baseline on the ETDRS DRSS Over Time | The DRSS will be graded according to ETDRS grading schedules from report 18 JOVS, February 1998, Vol. 39, No. 2. ETDRS DRSS is 13 step scale which measures severity of diabetic retinopathy (DR). The DRSS scores vary from 10 (DR absent) to 90 (ungradable proliferative diabetic retinopathy(PDR)). Higher levels indicate higher severity. | Up to Week 56 |
| Peoria |
| Arizona |
| 85381 |
| United States |
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States |
| Arkansas Retina Research | Little Rock | Arkansas | 72205 | United States |
| Global Research Management | Glendale | California | 91204 | United States |
| Retinal Consultants Medical Group | Modesto | California | 95356 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Medeye Associates | South Miami | Florida | 33143 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Retina Specialists of Tampa | Wesley Chapel | Florida | 33544 | United States |
| Center for Retina and Macula Disease | Winter Haven | Florida | 33880 | United States |
| Cumberland Valley Retina PC | Hagerstown | Maryland | 21740 | United States |
| Retina Associates of Michigan | Grand Blanc | Michigan | 48439-8301 | United States |
| Foundation for Vision Research | Grand Rapids | Michigan | 49546 | United States |
| Retina Consultants Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Mississippi Retina Associates | Madison | Mississippi | 39202 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Ross Eye Institute | Buffalo | New York | 14209-2102 | United States |
| Retina Associates of NY | New York | New York | 10075 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| Verum Research LLC | Eugene | Oregon | 97401 | United States |
| EyeHealth Northwest | Portland | Oregon | 97225 | United States |
| Erie Retinal Surgery | Erie | Pennsylvania | 16507 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Carolina Eyecare Physicians | Mt. Pleasant | South Carolina | 29464 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Austin Clinical Research LLC | Austin | Texas | 78750 | United States |
| Brown Retina Institute | Schertz | Texas | 78154 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
| Salt Lake Retina | West Jordan | Utah | 84088 | United States |
| Retina Group of Washington | Fairfax | Virginia | 20815 | United States |
| Emerson Clinical Research Institute | Falls Church | Virginia | 78503 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| Wagner Kapoor Institute | Norfolk | Virginia | 23502 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204-2509 | United States |
| Emanuelli Research and Development Center | Arecibo | 00612 | Puerto Rico |