Diabetic macular edema (DME) Eye Diseases
Conditions
Interventions
Current interventions as of 08/08/2023:
Part 1 Single Ascending Dose (SAD): Participants, in multiple cohorts, will receive a single dose of RO7446603, as ITV injection on Day 1, as guided by specif
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time of signing the Informed Consent Form 2. Documented diagnosis of diabetes mellitus (Type 1 or Type 2) 3. Macular thickening secondary to DME involving the center of the fovea 4. Decreased visual acuity attributable primarily to DME
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/08/2023: 1. Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1 2. Uncontrolled blood pressure (BP), defined as systolic >180 millimetres of mercury (mmHg) and /or diastolic >100 mmHg while the participants is at rest 3. Pregnancy or breastfeeding, or intention to become pregnant during the study 4. Participants with ITV anti-VEGF treatment within 3 months prior to Day 1 5. Participants with any ITV or periocular (subtenon) corticosteroid treatment within 6 months prior to Day 1 6. High-risk proliferative diabetic retinopathy (PDR) in the study eye 7. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision 8. Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye 9. Other protocol-specified inclusion/exclusion criteria may apply _____ Previous exclusion criteria: 1. Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1 2. Uncontrolled blood pressure (BP), defined as systolic >180 mmHg and/or diastolic >100 mmHg while the participants is at rest 3. Pregnancy or breastfeeding, or intention to become pregnant during the study 4. Participants with ITV anti-VEGF treatment within 3 months prior to Day 1 5. Participants with any ITV or periocular (subtenon) corticosteroid treatment within 6 months prior to Day 1 6. High-risk proliferative diabetic retinopathy (PDR) in the study eye 7. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision 8. Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye 9. Other protocol-specified inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 08/08/2023: 1. Percentage of participants with adverse events (AEs) from day 1 up to end of treatment or early termination visit (up to approximately 36 weeks) 2. Percentage of participants with severity of AEs determined according to Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events (HHS 2017) from day 1 up to end of treatment or early termination visit (up to approximately 36 weeks) 3. Number of participants with ocular AEs from day 1 up to end of treatment or early termination visit (up to approximately 36 weeks) 4. Number of participants with abnormal laboratory findings measured using blood and urine samples from screening up to end of treatment or early termination visit (up to approximately 36 weeks) 5. Number of participants with abnormal physical findings assessed by evaluation of the head, eyes, ears, nose, and throat, and measurement of height and weight from screening up to end of treatment or early termination visit (up to approximately 36 weeks) 6. Number of participants with abnormal vital signs assessed by measurement of temperature, respiratory rate, heart rate, and systolic and diastolic blood pressure from screening up to the end of treatment or early termination visit (up to approximately 36 weeks) 7. Number of participants with abnormal electrocardiogram (ECG) parameters measured using a standard high-quality, high-fidelity digital electrocardiograph machine from day 1 up to 8 weeks after last dose of study drug (up to approximately week 16) 8. Changes from baseline in Best-Corrected Visual Acuity (BCVA) score measured using a set of three Precision Vision™ or Lighthouse distance acuity charts from screening up to end of treatment or early termination visit (up to approximately 36 weeks) _____ Previous primary outcome measures as of 10/03/2023: 1. Percentage of participants with adverse events (AEs) from day 1 up to end of treatment or early termination visit | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed